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

NCT05780983 | Completed Results

• 2 other identifiers: IRB00089122P30AG021332
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder

Keywords

sleep-wake patterns; poor sleep

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  Total number of minutes asleep divided by total time in bed measure by wrist actigraph

  Month 2

Secondary Outcomes (3)

• Insomnia Severity Scores

  Month 2

• Total Daytime Activity

  Month 2

• Pittsburgh Sleep Quality Index Score

  Month 2

Study Arms (1)

education and coaching on developing healthy nighttime sleep and daytime activity behaviors

OTHER

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.

Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors

Interventions

education and coaching on developing healthy nighttime sleep and daytime activity behaviors BEHAVIORAL

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.

education and coaching on developing healthy nighttime sleep and daytime activity behaviors

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Jaime M Hughes, PhD, MPH, MSW
• Organization: Wake Forest University Health Sciences

jane.hughes@wfusm.edu

336-716 -0835

Study Officials

• Jaime M Hughes, PhD, MPH, MSW

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Older adults utilizing outpatient primary care clinics belonging Atrium Wake Forest Baptist Health. All activities will take place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors while at home.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: May 8, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)