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AnxietyNCT06353919

Remote Yoga Nidra for Deprescribing BZRAs

A study testing Yoga Nidra and Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education in people with Anxiety and Insomnia, run by National University of Natural Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Anxiety, Insomnia
What is being tested?
Yoga Nidra and Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Erica Sharpe, PhD contact

518-681-2580

esharpe@nunm.edu

Anders Gundersen, MS contact

503-451-0481

agundersen@nunm.edu

About this study

Official title: Remotely-delivered Yoga Nidra for Decreasing Use of BZRAs for Insomnia and Anxiety in Older Adults

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.

Read the detailed description

Before 2020, insomnia and anxiety were estimated to affect much of the US adult population at some point in their life (50% and 30% respectively). By summer of 2022, however, daily negative impacts of insomnia and anxiety were reported by 28% and 52% of US adults, respectively. In the absence of intervention, the COVID-19 pandemic will have lasting negative impacts on our society's sleep and mental health, plus contribute to increased mortality due to depression, heart disease and stroke resulting from insomnia and anxiety. Insomnia and anxiety often co-exist and generalized anxiety disorder is the most common co-morbid psychiatric condition diagnosed with insomnia, with 73% of individuals suffering from anxiety later developing insomnia. Although Benzodiazepine Receptor Agonists (BZRAs) provide rapid symptom relief, they carry risks of side effects including addictive potential, greater risk for falls and motor vehicle accidents, and potential respiratory failure resulting in death, especially when combined with other CNS suppressants such as opiates. Furthermore, many medications may require life-long use, and long-term safety and efficacy have not been established, plus cost remains a barrier to access and adherence. As a result, the first-line treatment for insomnia and anxiety is often Cognitive Behavioral Therapy (CBT). However, CBT is difficult to access, expensive, and takes 4-6 weeks before clinical benefit becomes evident. And it is not very effective in eliminating long-term BZRA use [18] or insomnia/anxiety (34% remission rate for individuals with insomnia and comorbid anxiety). Thus, there is need to test accessible, fast-acting therapies, as stand-alone treatments, or precursor therapies in a stepped care model with CBT-I, to decrease BZRAs used for insomnia and anxiety.

Mind-body therapies offer one solution as they are purported to increase self-efficacy and self-regulation, potentially helping to facilitate cognitive and behavioral change needed to decrease BZRA use, and to modify sleep and anxious thought patterns. Importantly, for individuals who struggle to fall asleep or stay asleep (often resulting when anxiety exists alongside insomnia) a fast-acting therapy needs to be accessible in the middle of the night. An effective mind-body therapy for comorbid insomnia and anxiety requires specific qualities such as ease of access, ease of adoption, and mechanisms that support sleep such as inducing relaxation.

Remotely-delivered interventions for insomnia and anxiety have been in greater demand since healthcare systems became strained by the pandemic. They offer a valuable opportunity for easy access, and there is evidence of effectiveness. Yet there remains room for improvement, and there has been limited research on remotely-delivered mind-body interventions. Yoga Nidra, a remotely-delivered 30-minute guided meditation (practiced by listening to a voice, while lying down with eyes closed) could be an excellent practice to address insomnia as it is relaxing, free, easily accessible, and only requires passive involvement. It naturally produces a hypnogogic state, which occurs during a normal transition to sleep and promotes a state of deep rest (with simultaneous release of physical, mental, and emotional tensions), accompanied by a unique change in awareness, allowing passive self-exploration, resolution, and growth. The practice is described in detail elsewhere, and is scripted, making it easily reproducible for research, clinical, and personal use. Importantly, this practice can be used at any time of day or night (including to help fall asleep) and requires no special physical capabilities or movements. Setting it apart from BZRAs or CBT-I, Yoga Nidra has no limitations for long-term use (such as side effects or cost) and in fact, ongoing practice provides regular opportunities for self-exploration and biopsychosocial benefit.

Relevance to Deprescribing in Older Adults: In spring of 2021, 32% of older adults had reported increased sleep disturbances since the start of the pandemic, and amongst those individuals 78% reported "trouble falling or staying asleep". Additionally, with 44% of older adults reporting self-medicating when they could not sleep, especially since COVID-19 began, risks must be considered. Further complicating matters, issues of polypharmacy and cognitive decline, make safe BZRA use more difficult to ensure in older adults. With 20-30% of older adults suffering daily from anxiety and insomnia, Yoga Nidra is a very promising, accessible, passive, low-cost, and rapid-acting intervention to turn to, instead of BZRAs, for help falling asleep, improving sleep quality, and decreasing anxiety. Yoga Nidra could be especially helpful to those with hypnotic-dependent insomnia, as it is traditionally used to break habits and addictions, with reports of practitioners spontaneously quitting smoking or drinking. This phenomenon was also observed in our work and is attributed to deeply tuning in to what is best for oneself. Description of the Population to be Served: This study will focus on adults in the US over age 65, who are using BZRAs for insomnia comorbid with anxiety, have been using them regularly for at least 3 months, and who are interested in decreasing or discontinuing usage.

Conditions
Anxiety, Insomnia
Being tested
Yoga Nidra, Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education
Keywords
Yoga, Anxiety, Insomnia, Benzodiazepine
Medical subject headings
Anxiety Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga NidraOther

    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.

  • Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist EducationOther

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

Study groups in NCT06353919
Study groupRoleWhat they receive
Yoga NidraExperimentalParticipants will practice 30 minutes of yoga nidra 3-5x's/week for 6 weeks
Receives: Other: Yoga Nidra
Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist EducationActive comparatorParticipants will review education material for 30 minutes at a time, 3-5x's/week for 6 weeks
Receives: Other: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demand

    Number of inquiries

    Measured: Up to one year

  2. Recruitment Success

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

    Measured: Up to one year

  3. Implementation practicality

    Whether the interventions can be successfully administered remotely in this population

    Measured: Up to one year

  4. Acceptability

    Comfort and tolerability ratings on a 0-100 scale

    Measured: 6 weeks

  5. Retention

    Attrition Rate

    Measured: 6 weeks

  6. Adherence to Protocol

    Percentage of participants who adhered to each intervention

    Measured: 6 weeks

Secondary outcomes (4)
  1. Use of Benzodiazepine Receptor Agonist medications

    Frequency and amount used during the study

    Measured: 6 weeks

  2. Cessation of Benzodiazepine Receptor Agonist medication

    Number of participants not taking Benzodiazepine medication by the end of the trial

    Measured: 6 weeks

  3. Baseline Urine Benzodiazepine Receptor Agonist Concentration

    Concentration of Benzodiazepine metabolites in urine

    Measured: Baseline

  4. Close-out Urine Benzodiazepine Receptor Agonist Concentration

    Concentration of Benzodiazepine metabolites in urine

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353919
Sponsor's protocol ID
NUNM
Status last verified
Aug 2024
First submitted
14 Nov 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Nidra and Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education in people with Anxiety and Insomnia, run by National University of Natural Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erica Sharpe, PhD (518-681-2580, esharpe@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demand (time frame: Up to one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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