An interventional study of Sleep extension intervention and Health education in Elevated Blood Pressure and Habitual Sleep Duration of Less Than or Equal to 7 Hours, sponsored by University of Utah. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
The goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.
Half of U.S. adults have at least one cardio-metabolic disease (CMD), including hypertension (HTN), heart disease, stroke, or diabetes. Even with advances in screening, education, and medication management, controlling these chronic diseases remains challenging. Despite the well-established negative effects of short sleep duration, surprisingly few studies have tested the benefits of sleep extension and even fewer studies evaluate the science of sleep extension interventions. Therefore, the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, CMD risk factors, and health behaviors among adults with elevated BP/HTN and short sleep duration.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the sleep extension group will receive a fitbit, weekly coaching calls and educational materials for 8 weeks. In months 3-6, they will receive educational materials and an email from the coach each month.
Behavioral: Sleep extension intervention
Participants in the health education group will receive 8 weekly health education emails and telephone calls to confirm their receipt and clarify any concepts from the materials. In months 3-6, they will receive monthly health education materials.
Behavioral: Health education
Participants will receive a fitbit and 8 weekly sleep-related educational materials via email and telephone coaching to review their sleep tracker data, set goals, trouble shoot any problems, and increase motivation.
Participants will receive 8 weekly health education newsletters delivered via email.
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Time frame: 8 weeks
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
Time frame: 8 weeks
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
Time frame: 12 months
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Time frame: 12 months
Diet
24 hour diet recall
Time frame: 8 weeks
Diet
24 hour diet recall
Time frame: 12 months
Physical activity
Accelerometer measured activity over 7 days
Time frame: 8 weeks
Physical activity
Accelerometer measured activity over 7 days
Time frame: 12 months
HbA1c
Cardiometabolic marker
Time frame: 12 months
C-reactive protein (CRP)
Cardiometabolic marker
Time frame: 8 weeks
C-reactive protein (CRP)
Cardiometabolic marker
Time frame: 12 months
IL-6
Cardiometabolic marker
Time frame: 8 weeks
IL-6
Cardiometabolic marker
Time frame: 12 months
Plan to share: Yes — Data will be made available upon request to the investigators at the end of the study.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Utah