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NCT05968820 · ClinicalTrials.gov registry record · Phase 1
Sleep Health Enhancement in Older Adults to Address Frailty
A Phase 1 study of Frailty, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05968820 is a Phase 1 study of Frailty that has completed, run by University of Kansas Medical Center. The registered enrollment target is 40 participants, below the 1,505-participant average among 48 other Frailty trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05968820, a Phase 1 study of Frailty, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Sleep Health Enhancement Intervention
Study Locations (1)
Kansas
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-09-12 |
| Est. Completion | 2024-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05968820
The ClinicalTrials.gov registry entry for NCT05968820 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,505-participant average among 48 other Frailty trials with a reported enrollment target (97% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Frailty appearing as the primary indexed condition, and to 1 intervention - of which Sleep Health Enhancement Intervention is the first listed.
NCT05968820 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT05968820 about?
NCT05968820 is a clinical study titled "Sleep Health Enhancement in Older Adults to Address Frailty". 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 a...
What is the current status of trial NCT05968820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-09-12. Estimated completion is 2024-08-30.
What conditions does trial NCT05968820 study?
This clinical trial studies the following conditions: Frailty.
What interventions are being tested in trial NCT05968820?
The interventions under investigation include: Sleep Health Enhancement Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05968820?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05968820 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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