N/A
Completed N=7
Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults
Source: ClinicalTrials.gov NCT05780983 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Sleep Efficiency — 95.1 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency |
95.1 | — |
| SECONDARY Insomnia Severity Scores |
9.67 | — |
| SECONDARY Total Daytime Activity |
5188 | — |
| SECONDARY Pittsburgh Sleep Quality Index Score |
1.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05780983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.