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

Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults

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

Study Overview

• Status: Completed
• Conditions: Insomnia Disorder
• Intervention / Treatment: Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency	Total number of minutes asleep divided by total time in bed measure by wrist actigraph	Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Scores	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.	Month 2
Total Daytime Activity	Daily activity (total count of steps), per wrist actigraph	Month 2
Pittsburgh Sleep Quality Index Score	Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance.	Month 2

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jaime M Hughes, PhD, MPH, MSW, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: poor sleep; sleep-wake patterns
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: IRB00089122; P30AG021332 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No