VERITAS shows virtual assistant with clinical oversight as effective as traditional physical therapy

October 15, 2018 – VERA™, a virtual rehabilitation platform, also enabled a substantial reduction in costs and rehospitalizations.

The DCRI and Reflexion Health today announced positive results from a randomized controlled clinical trial, “Virtual Exercise Rehabilitation In-home Therapy: A Research Study (VERITAS).” VERITAS was designed to evaluate the cost and clinical non-inferiority of using a virtual rehabilitation platform to deliver physical therapy following total knee replacement (TKR) surgery. In the study, VERA™, Reflexion Health’s FDA-cleared Virtual Exercise Rehabilitation Assistant, with clinician oversight enabled a substantial reduction in post-acute costs and rehospitalizations while being as effective as traditional physical therapy.

Conducted independently by the DCRI, VERITAS is the first large-scale randomized controlled clinical trial that compares virtual physical therapy with traditional physical therapy.

Janet Bettger“Physical therapy is a critical component of recovery for patients following total joint replacement surgery. As people live longer and these surgeries become more common, it is important to identify solutions that maintain or improve outcomes while decreasing the burden on patients and providers,” said the DCRI’s Janet Prvu Bettger, ScD, associate professor with the Duke Department of Orthopedic Surgery and principal investigator of the study. “We are pleased with the results of the study which show that Reflexion Health’s VERA coupled with remote clinician oversight, is a cost-effective paradigm for physical therapy – one that is more convenient for patients while providing clinicians greater insight into the recovery process.”

VERITAS was a multi-center, randomized controlled trial that enrolled 306 adult participants scheduled for TKR surgery at four U.S. sites. Of the consented participants, 287 completed the trial. The treatment group concluded with 143 adults who received Reflexion Health’s VERA both pre- and post-surgery, compared with a control group of 144 adults who received traditional in-home or clinic-based physical therapy at participating sites. Clinical outcomes, health service use, and costs were examined for three months after surgery.

The study results demonstrated an average cost savings of $2,745 per patient for those who received virtual physical therapy using VERA technology with clinical oversight when compared to usual care with traditional physical therapy. Virtual physical therapy met its secondary effectiveness endpoints of non-inferiority for reducing disability and improving knee function. Compared with usual care, safety endpoints for patients with virtual physical therapy were similar.

“VERITAS provides the highest level of evidence that VERA is a more cost-effective, patient-centered alternative to traditional care,” said Joseph Smith, MD, PhD, chief executive officer of Reflexion Health. “The strength of these results should give providers and payors the proof they need to adopt VERA. Engaging and delighting patients with a convenient and connected solution in the comfort of their own home, while providing similar or better clinical outcomes and dramatically reducing overall healthcare costs is a win for everyone.”

Full results from the VERITAS trial will be presented at the American Health Association of Hip and Knee Surgeons Annual Meeting taking place November 2-4 in Dallas.

DCRI’s CEC team hosts unique event with Stanford

October 11, 2018 – The Duke/Stanford CEC Summit brought together experts in clinical events classification from around the globe.

A unique, collaborative meeting aimed at establishing consistent standards globally for clinical events classification (CEC) and adjudication in clinical trials is being celebrated as a success and vital starting point for future work.

The first-ever Duke/Stanford CEC Summit was held Sept. 26-27 at the Chicago Hilton O’Hare, jointly hosted by the DCRI and the Stanford Center for Clinical Research (SCCR). Approximately 80 attendees took part in the two-day event.

“This meeting is all about bringing scientific rigor around CEC,” said Summit Co-Chair Renato Lopes, MD, PhD, faculty co-director of DCRI’s CEC team. “Our goal was to review how we do it now, but also predicting and trying to anticipate the future. Getting the right players in the room is critical – from academic, industry people, regulatory, and operational people – and try to share best practices, share experiences, and come to consensus. Or we recognize the things where there is no consensus, and there, try to innovate and inform the field.”

Numerous speakers and panelists from beyond Duke and Stanford supported that aim, with presenters representing the U.S. Food and Drug Administration (FDA), Harvard University, Cleveland Clinic, George Clinical, the Cardiovascular Research Foundation, ACI Clinical, Cardialysis, and more.

DCRI speakers included Professor of Biostatistics and Bioinformatics Frank Rockhold, PhD; CEC Co-Director Schuyler Jones, MD; CEC-Safety Surveillance Director of Operations Matt Wilson, RN; and Safety Surveillance Program Manager Ghazala Haque, MBBS, MHS.

Abraham Gutman, CEO of AGMednet – one of several CEC Summit sponsors – was impressed by the dialogue at the event, noting “people were able to ask the key questions that are in everybody’s mind, but never had a forum to ask.”

“I have heard a number of things (at the meeting) that are contradictory in a good way, in that people have different opinions,” he added. “My hope is that…we will find the commonalities in the processes that different people have been putting together and be able to use those more across projects in a way that…will achieve a better result.”

Event organizers look forward to sharing a white paper in the coming weeks that summarizes the learnings and opportunities identified at the meeting.

“This is just the beginning,” Lopes concluded. “We really hope that we’re going to create a core group of people that will meet every year and discuss and follow up on the action items …and move forward over the years. We can refine the discussion, we can create documents…that can model and help people do CEC all over the world.”

“I think this meeting is long overdue,” remarked Karen Hicks, medical officer with the U.S. FDA. “There was such active engagement – so many questions. There’s many CECs throughout the world and I think we’re all grappling with the same questions about how to do the job better.”

Curtis named Fellow of the American College of Medical Informatics

October 9, 2018 – Curtis and 17 others will be formally inducted into the College during the AMIA Annual Symposium next month.

DCRI Interim Executive Director Lesley Curtis, PhD, will be inducted into the American College of Medical Informatics (ACMI) on Nov. 4 at ceremonies during the American Medical Informatics Association (AMIA) 2018 Annual Symposium in San Francisco.

Curtis is one of 18 Fellows who will be inducted this year.

Lesley Curtis“The election of ACMI Fellows represents the strength and diversity of informatics with recognition of 18 accomplished individuals who are national and international subject matter experts in the science of informatics as it relates to clinical care, research, education and policy,” said ACMI President Christopher G. Chute, MD, DrPH, of Johns Hopkins University. “It reflects the growing impact of the field in health care.”

“I’ve had the pleasure of working closely with many informatics experts in the course of my career and have learned a great deal from them,” Curtis said. “It’s truly an honor to be inducted into the College.”

ACMI is an honorary College of elected Informatics Fellows from the United States and abroad who have made significant and sustained contributions to the field of medical informatics and who have met rigorous scholarly scrutiny by their peers. Incorporated in 1984, ACMI dissolved its separate corporate status to merge with the American Association for Medical Systems and Informatics (AAMSI) and the Symposium on Computer Applications in Medical Care (SCAMC), when AMIA was formed in 1989. The College now exists as an entity within AMIA, with its own bylaws and regulations.

AMIA, the leading professional association for informatics professionals, comprises 5,500 informatics professionals from more than 65 countries. AMIA and its members play a leading role in assessing the effect of health innovations on health policy and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.

In addition to serving as interim executive director of the DCRI, Curtis is also chair of the Department of Population Health Sciences. A health services researcher by training, Curtis has spent her career advancing the health of patients with cardiovascular disease, eye disease, and other chronic conditions. An expert in the use of Medicare claims data for health services and clinical outcomes research, she has been a leader in using Medicare claims data along with large clinical registries and epidemiological cohort studies, including the Framingham Heart Study and the Cardiovascular Health Study.

Curtis co-leads the Distributed Research Network Operations Center for PCORI’s National Clinical Research Network (PCORnet), is co-principal investigator of the National Institutes of Health’s Health Care Systems Collaboratory, and co-leads the Data Core for the FDA’s Sentinel Initiative.

Susanna Naggie receives IDSA’s Oswald Avery Award for Early Achievement

October 6, 2018 – The award, which recognizes infectious disease specialists under the age of 45, will be presented at ID Week in San Francisco.

The Infectious Diseases Society of America (IDSA) has presented its 2018 Oswald Avery Award for Early Achievement to the DCRI’s Susanna Naggie, MD, MHS, for her novel research on the treatment of patients co-infected with HIV and hepatitis C virus (HCV).

The award, which will be formally presented at ID Week 2018 in San Francisco, recognizes members or fellows of IDSA age 45 or younger who have demonstrated outstanding achievements in an area of infectious diseases.

“I was very surprised because I had no idea I’d been nominated,” Naggie said. “When I learned that two of my colleagues from outside of Duke nominated me, it meant a lot to know they found my work meaningful. As investigators we hope that our work is impactful and ultimately translates to improved health of our patients.”

Naggie’s research focuses on the mechanisms of accelerated liver fibrogenesis in HIV/HCV-infected patients. Her work has helped define the role of pharmacogenomics and mechanistic studies of HCV treatment response in these patients, including studies of single-nucleotide polymorphisms in HCV therapy and associated liver disease.

Her group was the first to report that black patients who carried the favorable CC genotype had more immune dysregulation than non-black patients without the favorable genotype. This research has laid an important foundation for understanding the disparity in HCV treatment response in co-infected African Americans.

“I have had fantastic mentorship at Duke and in the DCRI as well as externally,” Naggie said. “[Former Gastroenterology director] John McHutchison and Shyam Kottilil enabled me to get exposure that laid the groundwork for the work that we accomplished early on and the work that is ongoing. Many others have given me opportunities, for which I am very appreciative.”

Currently an associate professor of medicine at Duke University School of Medicine, where she has been a member of the faculty since 2009, Naggie is medical director of the Department of Medicine’s Clinical Research Unit and director of infectious diseases research at the DCRI. In addition to her own research, she has served as the primary mentor for many trainees, including interns, residents, fellows, and junior faculty.

Naggie has served as a member and co-chair of the IDSA and American Association for the Study of Liver Diseases HCV guidance panel, as a member of the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, and as a member or leader of several other notable national committees and groups. A graduate of Johns Hopkins University School of Medicine, Naggie completed her internship, residency, chief residency, and ID fellowship training at Duke, where she also earned a master of health sciences degree in clinical research.

USDRN receives additional funding for study of kidney stones

October 4, 2018 – The award from NIDDK will support the DCRI’s Scientific Data Research Center for the USDRN.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has awarded an additional $1.3 million over three years to the DCRI’s Charles Scales, MD, and Hussein Al-Khalidi, PhD, to support the Prevention of Urinary Stones with Hydration (PUSH) trial.

The PUSH study is a randomized trial that will enroll 1,642 people, half in an intervention group and half in a control group. The study’s primary aim is to determine whether use of a “smart” water bottle to stay hydrated, along with a program of financial incentives and health coaching, will result in reduced risk of urinary stone (also known as kidney stone) recurrence over a two-year period.

Kidney stones are small, hard mineral deposits that form inside the kidneys and can cause kidney damage and excruciating pain. Kidney stones affect about 1 out of 11 Americans. The prevalence of kidney stones among Americans has nearly doubled in the last 15 years, and is increasing in both adults and children.

According to the NIDDK, kidney stones cost an estimated $10 billion each year, making them the most expensive non-malignant urologic condition in the United States. A recent study estimates that the impact of obesity, diabetes and population rates will increase costs of kidney stones by $1.24 billion a year by 2030.

The PUSH study is being conducted through the Urinary Stone Disease Research Network (USDRN), a network of scientists and investigators conducting research on kidney stones in adults and children in order to learn more about who forms kidney stones, the best treatments, and how to prevent stones from forming.

PUSH is currently enrolling at four clinical centers: the University of Pennsylvania/Children’s Hospital of Philadelphia, the University of Texas Southwestern Medical Center in Dallas, the University of Washington in Seattle, and Washington University in St. Louis. The DCRI serves as the network’s Scientific Data Research Center, led by Scales and Al-Khalidi.

“I am grateful for the mentoring and outstanding research environment at Duke, which makes everything I do possible,” Scales said.

EASD 2018: Albiglutide superior to placebo in reducing MACE risk

October 2, 2018 – The results of the Harmony Outcomes study were published simultaneously in The Lancet.

GSK and the DCRI today announced publication of positive results from the Harmony Outcomes study, which assessed the cardiovascular (CV) safety and efficacy of albiglutide, a GLP-1 receptor agonist, in patients with type 2 diabetes and CV disease. Results were presented at the annual meeting of the European Association for the Study of Diabetes with simultaneous publication in The Lancet.

The study was initiated in July 2015 and GSK remained committed to completing it following an announcement in July 2017 of GSK’s intention to cease further R&D, manufacturing and sales activity for albiglutide (Tanzeum/Eperzan®). Prior studies of GLP-1 receptor agonists when used in patients with diabetes and CV disease had provided inconsistent results regarding the potential benefit, and GSK believed that the data generated from this study could contribute important new evidence to the field.

Adrian Hernandez

Harmony Outcomes was a randomized, double-blind, placebo-controlled study to assess the effect of albiglutide on major adverse CV events in 9,463 patients with type 2 diabetes and cardiovascular disease which took place at 610 sites in 28 countries. Patients were randomized to the addition of once-weekly subcutaneous injection of albiglutide 30mg (potentially increasing to 50 mg) or matching placebo in addition to standard care.

It was hypothesized that albiglutide would be noninferior to placebo for the primary outcome of first occurrence of cardiovascular death, myocardial infarction, or stroke. The study continued until  611 or more confirmed primary outcome events (CV death, myocardial infarction, or stroke) occurred over a median follow-up of at least 1.5 years.

The primary outcome showed that albiglutide, administered subcutaneously once-weekly in 9,463 patients over a median period of 1.6 years, was superior to placebo in reducing the risk of major adverse cardiovascular events (MACE) by 22 percent (95 percent confidence interval [CI] 10 percent to 32 percent) when used in addition to standard of care in patients with type 2 diabetes and cardiovascular disease (p<0.0001 for non-inferiority; p=0.0006 for superiority). MACE occurred in 7.1 percent (N=338) and 9.0 percent (N=428) of patients receiving albiglutide and placebo in addition to standard of care, respectively. Overall, the number of patients who would need to be treated with albiglutide to prevent one event over a median of 1.6 years was 50.

The incidence of acute pancreatitis was  less than 1 percent (10 patients for albiglutide; 7 patients for placebo), as was the incidence of pancreatic cancer (6 patients for albiglutide; 5 patients for placebo). No events of medullary thyroid carcinoma were observed, and other serious adverse events did not differ significantly between the two groups.

“This large cardiovascular outcome trial has shown impressive results for albiglutide in lowering the risk of major adverse cardiovascular events and adds important evidence that certain GLP-1 receptor agonists can improve cardiovascular outcomes,” said the DCRI’s Adrian F. Hernandez, MD, MHS, Duke’s vice dean for clinical research. “Despite the need for treatments to manage these events, there was uncertainty about the cardiovascular effects of GLP-1 receptor agonists as a class due to mixed results from previous studies. We are fortunate that all involved maintained their commitment to participants to complete the trial, which helps address this knowledge gap for patients and clinicians alike on the role of GLP-1 receptor agonists in diabetes.”

“We would like to thank all the investigators and patients who participated in this study,” said GSK’s John Lepore, senior vice president, R&D pipeline. “Harmony Outcomes was an important study for us to complete to generate new data and insights about the role of the GLP-1 receptor agonist class in the management of patients with diabetes and cardiovascular disease.  GSK continued to invest in this study following a decision last year to cease all other activities on albiglutide, and we continue to explore opportunities to divest this medicine to a company with the right expertise and resources to realize its full potential for patients.”

The DCRI welcomes two new faculty members

Oct. 1, 2018 – The new faculty members come from Duke’s Department of Biostatistics and Bioinformatics and Department of Population Health Sciences.

Hwanhee Hong, PhD

Hwanhee Hong, PhD, joined the DCRI on August 1 as an assistant professor in the Duke Department of Biostatistics and Bioinformatics. Most recently, she worked as a postdoctoral fellow at Johns Hopkins Bloomberg School of Public Health.

Hong received her master’s degree in biostatistics at Harvard University and her PhD in biostatistics at the University of Minnesota. She is a K99/R00 NIH grant recipient and serves as the principal investigator for “Estimating Population Effects in Mental Health Research Using Meta-Analysis.”

At the interface of statistical method development and biomedical application, Hong’s research aims to answer clinical and scientific questions in public health and medicine. She is interested in developing statistical methodologies for comparative effectiveness research, network meta-analysis, causal inference with error-prone covariates, borrowing information adaptively across different data sources, and generalizability of clinical study findings to target populations. Hong also enjoys developing and applying various methods directly motivated by real-world problems.

Keith Marsolo, PhD

Keith Marsolo, PhD, joined the DCRI on September 1 as an instructor in the Department of Population Health Sciences. He was most recently an associate professor in the Division of Biomedical Informatics at Cincinnati Children’s Hospital Medical Center (CCHMC).

Marsolo received his PhD in Computer Science from Ohio State University, where his research focus was data mining, specifically the modeling and classification of biomedical data. His current research interests include electronic health records, common data models, distributed research queries, and multi-center learning health systems.

While at CCHMC, Marsolo served as faculty advisor for the Data Services Shared Facility housed within Biomedical Informatics. He and the Data Services team supported a number of quality improvement and research networks affiliated with CCHMC, including ImproveCareNow, a 106-center quality improvement and research network that focuses on improving the care and outcomes of children with inflammatory bowel disease. With funding from the Agency for Healthcare Research and Quality, the team also developed an EHR-linked registry for ImproveCareNow that has now been extended to support a pragmatic clinical trial that is being funded by the Patient-Centered Outcomes Research Institute (PCORI).

Marsolo has also been heavily involved in PCORI’s National Patient-Centered Clinical Research Network (PCORnet). He served as a co-investigator in the PEDSnet Clinical Data Research Network and ImproveCareNow Patient Powered Research Network, and has worked with the DCRI team as part of the Distributed Research Network Operations Center (DRN OC) of the PCORnet Coordinating Center for several years. Marsolo currently works on activities related to the PCORnet Common Data Model and data curation (quality assessment) through his role on the leadership of the DRN OC. He was a co-chair of the PCORnet’s Data Standards, Security and Network Infrastructure (DSSNI) Task Force during Phase I of PCORnet, and a member of the Data Committee as part of Phase II, becoming chair in 2018. He also serves as a member of the Data Quality Subcommittee of the National Evaluation System for health Technology Coordinating Center (NESTcc).

Hidden health problems can appear up to two years after elective hip surgeries

September 28, 2018 – Even when surgeries are successful, patients report more pain, arthritis and other ailments.

Up to two years following elective, arthroscopic hip surgery, a substantial proportion of patients reported troubling new health issues ranging from sleep problems, to arthritis to cardiovascular disease.

While such problems can be transient and diminish as full mobility returns, the findings suggest that patients and doctors should be prepared to manage a variety of complications over time, even as the surgeries themselves are considered a success.

“Our study focused on a younger group — current and former military personnel ages 18-50 — and compared their medical records both before and after surgery,” said Daniel Rhon, DSc, an adjunct professor at the DCRI and lead author of a study published online Sept. 28 in the British Journal of Sports Medicine.

“Even among this younger group, the number and frequency of these hidden complications that arose after elective hip surgery suggests we should be taking a more wholistic approach, proactively assessing patients for risks other than the standard surgical complications we more commonly look for,” Rhon said.

Rhon and colleagues — including senior author Chad Cook, PhD (pictured), program director of Duke’s Doctor of Physical Therapy Program and member of the DCRI — conducted the observational study by examining Military Health System records of 1,870 former and current service members undergoing arthroscopic hip surgery between 2004-2013. Patient records were collected for the 12 months prior to and 24 months after surgery.

In their analysis, they identified incidences of mental health disorders, chronic pain, substance abuse issues, cardiovascular ailments, metabolic syndrome, arthritis and sleep problems that were noted in the patients’ medical records both before and after their elective hip surgeries.

Post-surgery incidences of all comorbidities after the procedure rose dramatically: mental health disorder increased 84 percent; chronic pain diagnoses soared 166 percent; substance abuse ticked up 57 percent; cardiovascular disorders rose 71 percent; metabolic syndrome cases rose 86 percent; arthritis spiked 132 percent; and sleep disorders jumped 111 percent.

“Hip arthoscopy is becoming more common even among younger people, and it can be quite successful in resolving chronic, painful conditions,” Cook said. “But it’s important to be prepared for a lengthy recovery. These are surgeries where people are prohibited from fully bearing weight for several weeks, so they can’t exercise, they can’t sleep comfortably, they are in pain.”

Rhon said disruptions in sleep can be particularly problematic. Without proper rest, the sense of pain escalates, leading to a negative spiral of fatigue and pain that then depresses mood, energy levels and general health.

“These issues are compounding on each other,” Rhon said. “Our study serves as an important alert to both doctors and patients. Armed with this knowledge, we can be vigilant in addressing these problems earlier and potentially stopping others from developing.”

In addition to Rhon and Cook, study authors include Tina Greenlee, Bryant Marchant, and Charles D. Sissel.

The research received support from the US Defense Health Agency.

New way of determining treatment for staph infections cuts antibiotic use

September 25, 2018 – A clinical algorithm is able to identify which patients can take antibiotics for fewer days.

Using a clinical checklist to identify eligible patients, doctors were able to shorten the antibiotic duration for patients with uncomplicated staphylococcal bloodstream infections by nearly two days, DCRI and Duke Health researchers report.

“Staphylococci are among the most common causes of blood infection in the country,” said the DCRI’s Thomas L. Holland, MD (pictured), lead author of a study appearing Sept. 25 in the Journal of the American Medical Association.

Holland and colleagues in the Staphylococcal Bacteremia Investigators initiative tested an algorithm that defines how long patients with staph bloodstream infections should receive IV antibiotics.

The algorithm is based on specific clinical characteristics, such as how long the patient has had a fever, blood culture results, findings of heart infection, and other criteria. These criteria help doctors determine whether the infection is simple, uncomplicated or complicated — the most severe — in which infection has spread to the heart, spine or some other site in the body.

The study included 509 patients with staph bloodstream infections at 16 medical centers in the U.S. and Spain. Roughly half of the patients were randomly assigned to receive the algorithm-guided duration of antibiotic. For the other half, doctors determined the duration of their antibiotic treatment based on standard practice.

Patients in both groups recovered at the same rate: 82 percent of the algorithm patients and 81.5 percent of the standard care patients had positive outcomes, according to the study.

Complications were also statistically similar between the two groups, with 32.5 percent of algorithm patients and 28.3 percent of standard practice patients developing an adverse event, such as the infection spreading or getting worse.

However, the data showed a significant difference in antibiotic duration among patients with simple and uncomplicated infections — those in which infection had not spread to other parts of the body.

For these patients, an algorithm-guided treatment plan allowed doctors to stop IV antibiotics almost two days sooner than similar patients receiving standard care (4.4 days versus 6.2 days).

“Any reductions in the use of antibiotics to treat these infections would be a significant benefit in our effort to fight antibiotic resistance, particularly when these measures can be undertaken without harm to patients,” Holland said.

“The big point of this study is doing the same with less,” said senior author Vance G. Fowler, MD, a member of the DCRI. “If we are able to have the same outcomes but use less antibiotics, that has tremendous benefit at all levels of care.”

Irregular sleep linked to worse outcomes in adults

September 21, 2018 – Adults with varied sleep-wake times weigh more, have higher blood sugar and risk of disease, according to a new study from Duke and DCRI researchers.

Sufficient sleep has been proven to help keep the body healthy and the mind sharp. But it’s not just an issue of logging at least seven hours of Z’s.

A new study on sleep patterns suggests that a regular bedtime and wake time are just as important for heart and metabolic health among older adults.

In a study of 1,978 older adults published online Sept. 21 by the journal Scientific Reports, researchers at Duke Health and the DCRI found people with irregular sleep patterns weighed more, had higher blood sugar, higher blood pressure, and a higher projected risk of having a heart attack or stroke within 10 years than those who slept and woke at the same times every day.

Irregular sleepers were also more likely to report depression and stress than regular sleepers, both of which are tied to heart health.

African-Americans had the most irregular sleep patterns compared to participants who were white, Chinese-American or Hispanic, the data showed.

The findings show an association — not a cause-and-effect relationship — between sleep regularity and heart and metabolic health.

“From our study, we can’t conclude that sleep irregularity results in health risks, or whether health conditions affect sleep,” said Jessica Lunsford-Avery, PhD, an assistant professor in psychiatry and behavioral sciences and the study’s lead author. “Perhaps all of these things are impacting each other.”

Still, the data suggest tracking sleep regularity could help identify people at risk of disease, and where health disparities may impact specific groups, such as African Americans.

“Heart disease and diabetes are extremely common in the United States, are extremely costly and also are leading causes of death in this country,” she said. “To the extent we can predict individuals at risk for these diseases, we may be able to prevent or delay their onset.”

Participants used devices that tracked sleep schedules down to the minute so researchers could learn whether even subtle changes — going to bed at 10:10 p.m. instead of the usual 10 p.m. — were linked to the health of participants. Their ages ranged from 54 to 93, and people with diagnosed sleep disorders such as sleep apnea were not included.

The study also tracked the duration of participants’ sleep and preferred timing — whether someone turned in early or was a night owl. According to these measures, people with hypertension tended to sleep more hours, and people with obesity tended to stay up later.

Of all three measures, however, regularity was the best at predicting someone’s heart and metabolic disease risk, the researchers found.

“While we’ve known for a while that lack of sleep is associated with poor health outcomes, there is now a growing body of evidence that the regularity of the sleep also matters,” said the DCRI’s Ann Marie Navar, MD, PhD, another of the study’s authors. “What’s potentially exciting here is that this is a very modifiable risk factor for many people. Finding extra time in the day for more hours of sleep may be harder than just going to bed at the same time.”

Researchers plan to conduct more studies over longer periods in hopes of determining how biology causes changes in sleep regularity and vice-versa.

“Perhaps there’s something about obesity that disrupts sleep regularity,” Lunsford-Avery said. “Or, as some research suggests, perhaps poor sleep interferes with the body’s metabolism which can lead to weight gain, and it’s a vicious cycle. With more research, we hope to understand what’s going on biologically, and perhaps then we could say what’s coming first or which is the chicken and which is the egg.”

In addition to Lunsford-Avery and Navar, study authors include Matthew M. Engelhard and Scott H. Kollins.