Sleep Technology Intervention to Target Cardiometabolic Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension

Conditions
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Elevated Blood Pressure, Habitual Sleep Duration of Less Than or Equal to 7 Hours

Intervention / Treatment
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* Behavioral: Sleep extension intervention
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral sleep extension group<br>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<br>* 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.<br>|
| Other: Health education<br>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<br>* Participants will receive 8 weekly health education newsletters delivered via email.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration | Sleep duration will be measured using wrist actigraphy for 7 days | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour ambulatory blood pressure | Ambulatory blood pressure glycemic control, lipids). | 8 weeks | 
| 24 hour ambulatory blood pressure | Ambulatory blood pressure glycemic control, lipids). | 12 months | 
| Sleep duration | Sleep duration will be measured using wrist actigraphy for 7 days | 12 months |