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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04766424
Other study ID # 10055552
Secondary ID 1R01NR018891-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 30, 2021
Est. completion date May 30, 2025

Study information

Verified date May 2024
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date May 30, 2025
Est. primary completion date June 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18-65 - 24h ABP readings indicating elevated blood pressure (BP) or hypertension (24h average systolic (SBP) of 115-145 mmHg or diastolic (DBP) of 75-90 mmHg). Patients taking antihypertensive medications will be permitted if stable dose for >8 weeks - Time in bed <8 hours and habitual sleep duration <7 hours via actigraphy; - Smartphone user - Able to read/write in English. Exclusion Criteria: - High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea AHI 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening - Resistant hypertension, defined as >4 antihypertensive medications or taking medications and standardized in lab BP >130 mmHg SBP or 80 mmHg DBP at screening History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis) - BMI>50 kg/m2 or arm circumference greater than extra large cuff - Presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder) - alcohol abuse on the Audit-C (score >4 for men, >3 for women) - drug use on the NIDA-Modified ASSIST (score >3),90 - moderate to severe depressive symptoms (PHQ-8 >10) - Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis) - Overnight work more than 1x per month - Use of hypnotic or stimulant medications - Situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults >1x per week - Inability to read or write in English - Pregnancy/desire to become pregnant during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep extension intervention
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.
Health education
Participants will receive 8 weekly health education newsletters delivered via email.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (3)

Lead Sponsor Collaborator
University of Utah National Institute of Nursing Research (NINR), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Diet 24 hour diet recall 8 weeks
Other Diet 24 hour diet recall 12 months
Other Physical activity Accelerometer measured activity over 7 days 8 weeks
Other Physical activity Accelerometer measured activity over 7 days 12 months
Other HbA1c Cardiometabolic marker 12 months
Other C-reactive protein (CRP) Cardiometabolic marker 8 weeks
Other C-reactive protein (CRP) Cardiometabolic marker 12 months
Other IL-6 Cardiometabolic marker 8 weeks
Other IL-6 Cardiometabolic marker 12 months
Primary Sleep duration Sleep duration will be measured using wrist actigraphy for 7 days 8 weeks
Secondary 24 hour ambulatory blood pressure Ambulatory blood pressure glycemic control, lipids). 8 weeks
Secondary 24 hour ambulatory blood pressure Ambulatory blood pressure glycemic control, lipids). 12 months
Secondary Sleep duration Sleep duration will be measured using wrist actigraphy for 7 days 12 months
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