Sleep Technology Intervention to Target Cardiometabolic Health

NCT04766424 | Active Not Recruiting DMC

• 2 other identifiers: 100555521R01NR018891-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sleep duration

  Sleep duration will be measured using wrist actigraphy for 7 days

  8 weeks

Secondary Outcomes (3)

• 24 hour ambulatory blood pressure

  8 weeks

• 24 hour ambulatory blood pressure

  12 months

• Sleep duration

  12 months

Other Outcomes (9)

• Diet

  8 weeks

• Diet

  12 months

• Physical activity

  8 weeks

Study Arms (2)

Behavioral sleep extension group

EXPERIMENTAL

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

Health education

OTHER

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

Interventions

Sleep extension intervention BEHAVIORAL

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.

Behavioral sleep extension group

Health education BEHAVIORAL

Participants will receive 8 weekly health education newsletters delivered via email.

Health education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• h 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• University of Illinois at Chicago: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Baron KG, Duffecy J, Simonsen S, Bress A, Conroy MB, Greene T, Allen C, Vallejo S. Sleep Technology Intervention to Target Cardiometabolic Health (STITCH): a randomized controlled study of a behavioral sleep extension intervention compared to an education control to improve sleep duration, blood pressure, and cardiometabolic health among adults with elevated blood pressure/hypertension. Trials. 2023 Oct 10;24(1):658. doi: 10.1186/s13063-023-07658-6.

  PMID: 37817267 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 23, 2021
• Study Start: March 30, 2021
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 1 year upon completion fo the study
• Access Criteria: Written request to the PI

Locations

US (1)