Remote Yoga Nidra for Deprescribing BZRAs

NCT06353919 | Not Yet Recruiting

• 1 other identifier: NUNM
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system.

Conditions

Anxiety; Insomnia

Keywords

Yoga; Anxiety; Insomnia; Benzodiazepine

Outcome Measures

Primary Outcomes (6)

• Demand

  Number of inquiries

  Up to one year

• Recruitment Success

  Whether 30 participants will enroll and complete the 6-week study

  Up to one year

• Implementation practicality

  Whether the interventions can be successfully administered remotely in this population

  Up to one year

• Acceptability

  Comfort and tolerability ratings on a 0-100 scale

  6 weeks

• Retention

  Attrition Rate

  6 weeks

• Adherence to Protocol

  Percentage of participants who adhered to each intervention

  6 weeks

Secondary Outcomes (4)

• Use of Benzodiazepine Receptor Agonist medications

  6 weeks

• Cessation of Benzodiazepine Receptor Agonist medication

  6 weeks

• Baseline Urine Benzodiazepine Receptor Agonist Concentration

  Baseline

• Close-out Urine Benzodiazepine Receptor Agonist Concentration

  Week 6

Other Outcomes (8)

• Insomnia Severity Index

  Baseline

• Insomnia Severity Index

  Week 6

• Insomnia Severity Index

  Month 1

Study Arms (2)

Yoga Nidra

EXPERIMENTAL

Participants will practice 30 minutes of yoga nidra 3-5x's/week for 6 weeks

Other: Yoga Nidra

Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education

ACTIVE COMPARATOR

Participants will review education material for 30 minutes at a time, 3-5x's/week for 6 weeks

Other: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education

Interventions

Yoga Nidra OTHER

Recordings were created to allow participants access to a variety of Yoga Nidra practices. Participants will be instructed to complete a 30-minute Yoga Nidra 3-5 times per week, at any time of day or night (including before bed and/or during bouts of sleeplessness). This duration and frequency is informed by previous studies. Related to intentionally decreasing BZRA use, the recording requests each practitioner to set a resolve/personal goal at the start of each practice, and they are asked to repeat it again at the end. In our study, participants will be asked to develop a short and simple resolve in their own words, related to reducing BZRA use, improving sleep and decreasing anxiety, and they will be asked to recite it at each practice.

Yoga Nidra

Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education OTHER

Participants will be instructed to access excerpts from standardized and trusted materials through our online platform for 30 minutes, 3-5 times per week.

Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• over 65 years of age
• Use of benzodiazepine receptor agonist medication at least 3 nights per week for a minimum of three months and wish to decrease their use
• Ability to speak, read, and understand English
• Ability to sit or lie comfortably for 30 minutes at a time
• Must be under the care of a primary care provider

You may not qualify if:

• current use of sleep or anxiety medication other than benzodiazepine receptor agonists
• severe depression as indicated by a score above 20 on the patient health questionnaire
• presence of other comorbidities that may impact sleep i.e. restless leg syndrome, narcolepsy, or others)
• regular mind/body practice within 6 months
• unavoidable lifestyle disruptions to sleep

Sponsors & Collaborators

• National University of Natural Medicine: lead
• US Department of Veterans Affairs: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ryan Bradley, ND,MPH

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Sharpe, PhD

CONTACT

518-681-2580; esharpe@nunm.edu

Anders Gundersen, MS

CONTACT

503-451-0481; agundersen@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Helfgott Research Institute

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: April 9, 2024
• Study Start: October 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08