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Behavioural Intervention

Feasibility, Adherence and Acceptability Measure for Insomnia

N/A

Recruiting

Led By Gurjeet Birdee

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month

65 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to12 weeks

Awards & highlights

Study Summary

This trial aims to determine if a new combination of treatments can help older adults reduce their use of benzodiazepine or similar medications. The treatment involves gradually reducing the medication dose over 12 weeks

Who is the study for?

This trial is for older adults who are currently using benzodiazepines or similar medications to manage anxiety or insomnia and wish to reduce their medication use. Participants should be willing to engage in a 12-week program involving dose reduction, acupuncture, and yoga.Check my eligibility

What is being tested?

The study tests whether combining medical visits for gradual medication reduction with acupuncture treatments and private yoga classes can help older adults decrease their use of benzodiazepines over a period of 12 weeks.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of acupuncture, muscle soreness from yoga, and withdrawal symptoms such as increased anxiety or sleep disturbances from reducing benzodiazepine usage.

Eligibility Criteria

Inclusion Criteria

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

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I have taken benzodiazepines or similar medications at least 4 times in the last month.

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I am 65 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

BRZA dose change

Secondary outcome measures

Anxiety

Insomnia

Proportion of participants whom the investigators collect primary and .

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feasibility, Adherence and Acceptability MeasureExperimental Treatment3 Interventions

Assay of feasibility of study enrollment and feasibility of study treatments, the latter of which is measured via fidelity, adherence, and acceptability of/to treatments and interventions. Interventions administered for 12 weeks. Fidelity, adherence, and acceptability will be measured via patient survey and engagement.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,163 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,855 Total Patients Enrolled

9 Trials studying Insomnia

1,745 Patients Enrolled for Insomnia

Gurjeet BirdeePrincipal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

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

Are potential participants currently able to apply for this ongoing medical study?

"Indeed, the data available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible participants. The study was originally published on December 14th, 2023 and underwent its most recent update on December 26th, 2023. In total, the trial aims to enroll a cohort of 30 patients from one designated location."

Answered by AI

What is the cumulative count of individuals who are participating in this clinical study?

"Indeed, the information provided on clinicaltrials.gov confirms that this trial is actively seeking eligible candidates. The trial was initially posted on December 14th, 2023 and recently updated on December 26th, 2023. The study aims to enroll a total of 30 patients from one designated site."

Answered by AI