Sleep Technology Intervention to Target Cardiometabolic Health (STITCH)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Elevated Blood Pressure; Habitual Sleep Duration of Less Than or Equal to 7 Hours
• Intervention / Treatment: Behavioral: Sleep extension intervention; Behavioral: Health education

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral sleep extension group; 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 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.
Other: 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: Health education; Participants will receive 8 weekly health education newsletters delivered via email.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet	24 hour diet recall	8 weeks
Diet	24 hour diet recall	12 months
Physical activity	Accelerometer measured activity over 7 days	8 weeks
Physical activity	Accelerometer measured activity over 7 days	12 months
HbA1c	Cardiometabolic marker	12 months
C-reactive protein (CRP)	Cardiometabolic marker	8 weeks
C-reactive protein (CRP)	Cardiometabolic marker	12 months
IL-6	Cardiometabolic marker	8 weeks
IL-6	Cardiometabolic marker	12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Nursing Research (NINR); University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): June 14, 2024
• Study Completion (Estimated): June 14, 2025

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 10055552; 1R01NR018891-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request to the investigators at the end of the study.
• IPD Sharing Time Frame: Within 1 year upon completion fo the study
• IPD Sharing Access Criteria: Written request to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No