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NCT07862348NARecruiting

Sleep Better, Live Better Study

University of Alabama at Birmingham

Start Date

10/1/2026

Completion Date

7/31/2027

Summary

The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.

Detailed Description

Sleep disruption is a common and modifiable behavioral risk factor associated with hypertension, impaired glucose regulation, systemic inflammation, cognitive dysfunction, and cardiovascular disease. Poor sleep is highly prevalent in the Southeastern United States, where rates of cardiometabolic disease and cognitive decline are disproportionately high. Despite growing recognition of sleep as a core component of cardiovascular and brain health, sleep health is rarely addressed in routine primary care beyond general sleep hygiene recommendations. Adults with elevated cardiometabolic risk often experience competing demands, chronic stress, and multiple comorbidities that make sustained sleep behavior change difficult. Low-cost, scalable behavioral sleep programs that can be integrated into primary care settings are needed. This study will provide preliminary data needed to inform future larger-scale behavioral sleep studies and implementation focused research in high-risk primary care populations.

Eligibility Criteria

Age Range: 25 years to 65 years

Inclusion Criteria: 1. Adults ages 25-65; 2. Self-reported sleep duration \<7 hours per night; 3. Elevated cardiometabolic risk, i.e., presence of one or more of the following - hypertension, obesity, hyperlipidemia, diabetes; 4. Sleep is a behavioral target that individual wants to improve; 5. Complete eligibility screening procedures: Insomnia Severity Index (ISI-7), STOP-BANG, Epworth Sleepiness Scale (ESS); 6. Access to a smartphone, capable of receiving text messages and text links; 7. Able to speak and read English; 8. Willing and able to provide informed consent and participate in all study procedures Exclusion Criteria: 1. Exceeds eligibility screening thresholds: ISI-7 score ≥22, STOP-BANG score ≥5, ESS score ≥11; 2. Unable to complete study procedures in English; 3. No access to mobile phone with text messaging features; 4. Pregnancy

Interventions

BEHAVIORAL

Sleep Better, Live Better

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Conditions

Sleep HygieneSleep DurationHealth BehaviorSelf EfficacySleep

Locations

University of Alabama at Birmingham (UAB)

Birmingham, Alabama 35294

United States