Sleep Technology Intervention to Target Cardiometabolic Health (STITCH)

• ClinicalTrials.gov Identifier: NCT04766424
• Recruitment Status: Recruiting
• First Posted: February 23, 2021
• Last Update Posted: May 27, 2021
• Sponsor: University of Utah
• Collaborators: University of Illinois at Chicago; National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Kelly Glazer Baron, University of Utah

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Elevated Blood Pressure; Habitual Sleep Duration of Less Than or Equal to 7 Hours	Behavioral: Sleep extension intervention; Behavioral: Health education	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Investigators and outcomes assessors will not have access to the randomization table. Outcomes assessors will not be involved in the group assignments. Participants will be instructed to not tell outcomes assessors which group they are assigned to.
• Primary Purpose: Treatment
• Official Title: Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
• Actual Study Start Date: March 30, 2021
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: March 30, 2025

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Sleep duration [ Time Frame: 8 weeks ]
   Sleep duration will be measured using wrist actigraphy for 7 days

Secondary Outcome Measures :

1. 24 hour ambulatory blood pressure [ Time Frame: 8 weeks ]
   Ambulatory blood pressure glycemic control, lipids).
2. 24 hour ambulatory blood pressure [ Time Frame: 12 months ]
   Ambulatory blood pressure glycemic control, lipids).
3. Sleep duration [ Time Frame: 12 months ]
   Sleep duration will be measured using wrist actigraphy for 7 days

Other Outcome Measures:

1. Diet [ Time Frame: 8 weeks ]
   24 hour diet recall
2. Diet [ Time Frame: 12 months ]
   24 hour diet recall
3. Physical activity [ Time Frame: 8 weeks ]
   Accelerometer measured activity over 7 days
4. Physical activity [ Time Frame: 12 months ]
   Accelerometer measured activity over 7 days
5. HbA1c [ Time Frame: 12 months ]
   Cardiometabolic marker
6. C-reactive protein (CRP) [ Time Frame: 8 weeks ]
   Cardiometabolic marker
7. C-reactive protein (CRP) [ Time Frame: 12 months ]
   Cardiometabolic marker
8. IL-6 [ Time Frame: 8 weeks ]
   Cardiometabolic marker
9. IL-6 [ Time Frame: 12 months ]
   Cardiometabolic marker

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Kelly Baron, Ph.D.; 8015857588; kelly.baron@utah.edu

Contact: Sofia Vallejo; 8015851123; sofia.vallejo@hsc.utah.edu

Locations

United States, Utah

University of Utah; Recruiting

Salt Lake City, Utah, United States, 84108

Contact: Sofia Vallejo, PhD sofia.vallejo@utah.edu

Contact: Kelly Baron, PhD 801-585-7588 kelly.baron@utah.edu

Sponsors and Collaborators

University of Utah

University of Illinois at Chicago

National Institute of Nursing Research (NINR)

More Information

• Responsible Party: Kelly Glazer Baron, Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04766424
• Other Study ID Numbers: 10055552; 1R01NR018891-01A1 ( U.S. NIH Grant/Contract )
• First Posted: February 23, 2021
• Last Update Posted: May 27, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be made available upon request to the investigators at the end of the study.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Within 1 year upon completion fo the study
• Access Criteria: Written request to the PI

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases