Sleep Health Enhancement in Older Adults to Address Frailty - Trial NCT05968820
Access comprehensive clinical trial information for NCT05968820 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Kansas Medical Center and is currently Not yet recruiting. The study focuses on Frailty. Target enrollment is 40 participants.
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Study Focus
Sponsor & Location
University of Kansas Medical Center
Timeline & Enrollment
Phase 1
Aug 01, 2023
Aug 01, 2024
Primary Outcome
6-item Acceptability Scale,semi-standardized qualitative interview,Tilburg Frailty Indicator,WHOQOL-BREF,Ru_SATED sleep health composite
Summary
The objective of the proposed study is to tailor a sleep health enhancement intervention to
 older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot
 study will be conducted in two stages. In the treatment development stage, we will recruit
 n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report
 questionnaire) to assess acceptability and tailor the sleep health enhancement intervention
 for older adults. In the pilot study stage to assess preliminary efficacy of the tailored
 sleep health enhancement intervention, n=30 older adults with poor sleep health will be
 randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement
 intervention or to a wait-list control condition. Participants will wear wrist-worn
 actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and
 reassessments.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05968820
Non-Device Trial