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COMPLETED Phase 1

Sleep Health Enhancement in Older Adults to Address Frailty

NCT05968820 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 40 participants
Start Date 2023-09-12
Est. Completion 2024-08-30
Phase Phase 1

Sponsor

University of Kansas Medical Center

454 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 454 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05968820 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05968820?

The interventions under investigation include: Sleep Health Enhancement Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05968820?

This trial is sponsored by University of Kansas Medical Center, which has 454 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial