Insomnia Disorder Clinical Trial
— SWELL24Official title:
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency | Total time asleep/total time in bed, per wrist actigraph | Month 2 | |
Secondary | 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 | |
Secondary | total daytime activity | Daily activity (total count), per wrist actigraph | Month 2 | |
Secondary | daytime consequences | per self-reported assessment, daily diary | Month 2 |
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