Sleep Technology Intervention to Target Cardiometabolic Health

Elevated Blood Pressure Clinical Trial

— STITCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766424
• Other study ID #: 10055552
• Secondary ID: 1R01NR018891-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: Kelly Baron, Ph.D.
• Phone: 8015857588
• Email: kelly.baron[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Habitual Sleep Duration of Less Than or Equal to 7 Hours
• Hypertension

Intervention

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 will receive 8 weekly health education newsletters delivered via email.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Institute of Nursing Research (NINR), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diet	24 hour diet recall	8 weeks
Other	Diet	24 hour diet recall	12 months
Other	Physical activity	Accelerometer measured activity over 7 days	8 weeks
Other	Physical activity	Accelerometer measured activity over 7 days	12 months
Other	HbA1c	Cardiometabolic marker	12 months
Other	C-reactive protein (CRP)	Cardiometabolic marker	8 weeks
Other	C-reactive protein (CRP)	Cardiometabolic marker	12 months
Other	IL-6	Cardiometabolic marker	8 weeks
Other	IL-6	Cardiometabolic marker	12 months
Primary	Sleep duration	Sleep duration will be measured using wrist actigraphy for 7 days	8 weeks
Secondary	24 hour ambulatory blood pressure	Ambulatory blood pressure glycemic control, lipids).	8 weeks
Secondary	24 hour ambulatory blood pressure	Ambulatory blood pressure glycemic control, lipids).	12 months
Secondary	Sleep duration	Sleep duration will be measured using wrist actigraphy for 7 days	12 months