Status:
ACTIVE_NOT_RECRUITING
Sleep Technology Intervention to Target Cardiometabolic Health
Lead Sponsor:
University of Utah
Collaborating Sponsors:
University of Illinois at Chicago
National Institute of Nursing Research (NINR)
Conditions:
Elevated Blood Pressure
Habitual Sleep Duration of Less Than or Equal to 7 Hours
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 bl...
Detailed 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 manag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04766424
Start Date
March 30 2021
End Date
June 14 2025
Last Update
June 25 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108