Sleep Technology Intervention to Target Cardiometabolic Health

Not Applicable

Active, not recruiting

• Conditions: Elevated Blood Pressure; Habitual Sleep Duration of Less Than or Equal to 7 Hours
• Interventions: Behavioral: Health education; Behavioral: Sleep extension intervention

• Registration Number: NCT04766424
• Lead Sponsor: University of Utah

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 blood pressure/hypertension and short sleep duration.

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 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.

Study Timeline

• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Study Start: 2021-03-30
• Status Verified: 2024-06
• Primary Completion: 2024-06-14
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Study Completion: 2025-06-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education	Health education	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 sleep extension group	Sleep extension intervention	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.

Primary Outcome Measures

Name	Time	Method
Sleep duration	8 weeks	Sleep duration will be measured using wrist actigraphy for 7 days

Secondary Outcome Measures

Name	Time	Method
Sleep duration	12 months	Sleep duration will be measured using wrist actigraphy for 7 days
24 hour ambulatory blood pressure	12 months	Ambulatory blood pressure glycemic control, lipids).

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States