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Behavioral Intervention

Sleep Health Enhancement Intervention for Frailty

Phase 1

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥65 years old

≤ 7 on the RU-SATED self-report questionnaire

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 week and 12 week reassessments

Awards & highlights

Study Summary

This trial aims to develop and test a sleep improvement program for older adults, with the goal of reducing frailty. The study will be conducted in two stages. In the first stage, 10 older

Who is the study for?

This trial is for older adults aged 65 or above who are experiencing poor sleep health, as indicated by a score of 7 or less on the Ru-SATED questionnaire. They must also have generally intact cognitive function, with an MMSE score of at least 25 and an AD8 dementia screening interview score below 3.Check my eligibility

What is being tested?

The study is testing a sleep health enhancement intervention tailored for older adults to see if it can reduce frailty. The first stage involves refining the program with feedback from participants. In the second stage, participants will either receive this intervention through telehealth once a week for four weeks or be placed in a wait-list control group.See study design

What are the potential side effects?

Since this trial focuses on non-invasive sleep interventions delivered via telehealth, significant side effects are not anticipated. However, changes in sleep patterns could potentially lead to temporary discomfort such as fatigue or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 week and 12 week reassessments

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 week and 12 week reassessments

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 week and 12 week reassessments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6-item Acceptability Scale

Ru_SATED sleep health composite

Tilburg Frailty Indicator

+2 more

Secondary outcome measures

Actigraphy

Dysfunctional Beliefs About Sleep

Epworth Sleepiness Scale

+2 more

Other outcome measures

15 ft walk test

6-Minute Walk Test (6MWT)

Cognitive Failures Questionnaire (CFQ)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Health Enhancement InterventionExperimental Treatment1 Intervention

The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention.

Group II: Wait-List Control GroupActive Control1 Intervention

The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment.

0 / 3Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,230 Total Patients Enrolled

2 Trials studying Frailty

174 Patients Enrolled for Frailty

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"Indeed, according to the details available on clinicaltrials.gov, this trial is actively seeking eligible participants. The trial was initially posted for recruitment on September 12th, 2023 and underwent its most recent update on January 11th, 2024."

Answered by AI

Has the Sleep Health Enhancement Intervention received official approval from the FDA?

"Based on our assessment at Power, the safety rating for the Sleep Health Enhancement Intervention is a 1. This determination aligns with it being a Phase 1 trial where there is limited available data supporting both safety and efficacy."

Answered by AI

How large is the participant pool for this clinical study?

"Indeed, as per the data available on clinicaltrials.gov, this trial is currently actively seeking eligible candidates. The initial posting of the trial was dated 9/12/2023 and it was last updated on 1/11/2024. The study aims to enroll a total of 40 patients at a single location."

Answered by AI

What is the primary objective of this particular research endeavor?

"The primary objective of this clinical trial, to be evaluated over a period of approximately 6 weeks, involves conducting semi-standardized qualitative interviews. Secondary outcomes include assessing participants' sleep quality using the Pittsburgh Sleep Quality Index (PSQI), where higher scores indicate poorer sleep quality on a scale ranging from 0 to 21. Additionally, the Epworth Sleepiness Scale (ESS) will be utilized to measure daytime sleepiness through eight scenarios rated on a four-point Likert scale; scores range from 0 to 24 with higher values indicating increased sleepiness. Lastly, Dysfunctional Beliefs About Sleep will be assessed utilizing a self-report questionnaire"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Health Enhancement in Older Adults to Address Frailty

Catherine Siengsukon, PT, PhD 2023. "Sleep Health Enhancement in Older Adults to Address Frailty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968820.