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Randomized Controlled Trial
. 2023 Oct 10;24(1):658.
doi: 10.1186/s13063-023-07658-6.

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

Kelly Glazer Baron  1 , Jennifer Duffecy  2 , Sara Simonsen  3 , Adam Bress  4 , Molly B Conroy  5 , Tom Greene  3 , Chelsea Allen  3 , Sofia Vallejo  6
Affiliations
Randomized Controlled Trial

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

Kelly Glazer Baron et al. Trials. .

Abstract

Background: Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer mental health. Despite the prevalence of short sleep duration, few studies have tested interventions to extend sleep duration. The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of cardiometabolic health among adults with elevated blood pressure or hypertension.

Methods: This is a single-blind, randomized controlled trial to determine the impact of a behavioral sleep extension intervention on sleep duration and cardiometabolic health among individuals with short sleep duration (< 7 h per night) and elevated blood pressure or hypertension (SBP 120-150 mmHg or DBP 80-90 mmHg). After completing the screening, participants will be randomly assigned to either a sleep coaching (intervention) or health education (control) group. The participants will have weekly contact for either coaching or education for 8 weeks (intervention period) followed by monthly coaching or education for the next 2 months (maintenance period). Participants will complete assessment visits, actigraphy, and 24-h ambulatory blood pressure recording at baseline/screening, 8 weeks, and 6 and 12 months. The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks.

Discussion: The results of this study will determine the effects of behavioral sleep extension on sleep and cardiometabolic health among adults with short sleep duration and elevated BP/hypertension. The results will inform the feasibility and efficacy of behavioral sleep extension and provide information needed for future multi-site effectiveness studies.

Trial registration: ClinicalTrials.gov NCT04766424. Registered on 21 February 2021.

Keywords: Cardiometabolic disease (CMD); Diastolic blood pressure (DBP); Hypertension (HTN); Sleep; Sleep coaching; Systolic blood pressure (SBP).

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT-style flow chart for the trial
Fig. 2
Fig. 2
Schedule of time points, study assessments, and interventions
Fig. 3
Fig. 3
Educational content
Fig. 4
Fig. 4
A description of the participant timeline
See this image and copyright information in PMC

References

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