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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: Completed Phase 1 study of Frailty, sponsored by University of Kansas Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction

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

FieldValue
Enrollment Target 40 participants
Start Date 2023-09-12
Est. Completion 2024-08-30
Phase Phase 1
University of Kansas Medical Center

408 total trials

What the finished NCT05968820 record still lists

NCT05968820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,505-participant average among 48 other Frailty trials with a reported enrollment target (97% lower).

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 a single indexed study location in 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.

Similar trials for Frailty

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05968820's enrollment target sits among peer trials

40 32nd of 48 higher than 14 of 48 other Frailty trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Frailty trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05968820, the US trial registry maintained by the National Library of Medicine. NCT05968820 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.