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OpenTrials
Completed

NCT Number: NCT05780983

Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in 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.

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sleep Efficiency

    Time frame: Month 2

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

Secondary outcomes

  1. Insomnia Severity Scores

    Time frame: 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.

  2. Total Daytime Activity

    Time frame: Month 2

    Daily activity (total count of steps), per wrist actigraph

  3. Pittsburgh Sleep Quality Index Score

    Time frame: Month 2

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SWELL24

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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