Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults

Not Applicable

Completed

• Conditions: Insomnia Disorder
• Interventions: Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors

• Registration Number: NCT05780983
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.

Detailed Description

An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-23
• Study Start: 2024-05-08
• Primary Completion: 2024-10-28
• Study Completion: 2024-10-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Age 65 or over
• One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months
• Meets diagnostic criteria for Insomnia Disorder
• Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener
• Able to ambulate safely (with or without an assistive device)
• Able to follow study directions
• Able to communicate and follow study instructions
• English speaking

Exclusion Criteria

• Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome)
• Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder)
• Lack of decision-making capacity, as documented in medical record
• Referred to institutional care and/or currently residing in a nursing home or other residential facility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
education and coaching on developing healthy nighttime sleep and daytime activity behaviors	education and coaching on developing healthy nighttime sleep and daytime activity behaviors	The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.

Primary Outcome Measures

Name	Time	Method
Sleep efficiency	Month 2	Total time asleep/total time in bed, per wrist actigraph

Secondary Outcome Measures

Name	Time	Method
total daytime activity	Month 2	Daily activity (total count), per wrist actigraph
Insomnia severity scores	Month 2	Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity.
daytime consequences	Month 2	per self-reported assessment, daily diary

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States