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Augmenting Benzodiazepin Receptor Agonist Beskriv med akupunktur og yoga blandt ældre voksne

4. september 2026 opdateret af: Gurjeet Birdee, Vanderbilt University Medical Center

Augmenting Benzodiazepin Receptor Agonist Beskriv med akupunktur og yoga

The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (BRZA) to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga. Adults 65 years or older that are taking BRZA will be recruited. Deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the Osher Center for Integrative Health at Vanderbilt University Medical Center. Participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the Osher Center. Feasibility of study enrollment will occur through the study enrollment period. Feasibility of study treatments will be evaluated during and after study treatment delivery. Feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. Throughout the research process, investigators will engage a Stakeholder Advisory Panel consisting of patients and clinicians.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Osher Center for Integrative Health at Vanderbilt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 65 years and older
  • Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month
  • English speaking
  • Ability to understand study procedures and to comply with them for the length of the study

Exclusion Criteria:

  • Cognitive impairment
  • Drinking more than 3 alcoholic beverages per day
  • Substance abuse disorder
  • Uncontrolled psychiatric disorder, such as major depression or psychosis
  • Inability or unwillingness of individual or legal guardian.representative to give written informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Feasibility, Adherence and Acceptability Measure

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.
Andet: Acupuncture

Patients will receive acupuncture for 12 weeks.

Andet: Yoga

Patients will receive yoga therapy with one of three yoga instructors. Patients will remain with singular yoga instructor for duration of study. It is anticipated that patients will participate in yoga therapy for 12 weeks at home and in-clinic.

Andet: Deprescribing

Deprescribing of patients' benzodiazepine use will be monitored by psychiatric nurse. Tapering method will be followed for medication deprescription.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BRZA Dose Change
Tidsramme: Baseline to 12 weeks

Dose of BRZA for patients will be measured at baseline and 12 weeks
Baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia
Tidsramme: Baseline to12 weeks

Will use Patient Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Computerized Adaptive Testing to assess difficulties staying and falling asleep. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
Baseline to12 weeks
Anxiety
Tidsramme: Baseline to 12 weeks

Will use Patient Reported Outcomes Measurement Information System(PROMIS) Anxiety Computerized Adaptive Testing. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
Baseline to 12 weeks
Proportion of Participants Whom the Investigators Collect Primary and Secondary Outcomes.
Tidsramme: Baseline to 12 weeks

Will estimate feasibility of data collection for study measures by calculating proportion of participants whom the investigators collect primary and secondary outcomes.
Baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt University Medical Center

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Gurjeet Birdee, Vanderbilt University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. december 2023

Primær færdiggørelse (Faktiske)

23. maj 2025

Studieafslutning (Faktiske)

23. maj 2025

Datoer for studieregistrering

Først indsendt

26. december 2023

Først indsendt, der opfyldte QC-kriterier

26. december 2023

Først opslået (Faktiske)

9. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 230716
  • R24AG064025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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