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.
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
- 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.
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.
- 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 group | Role | What they receive |
|---|---|---|
| Yoga Nidra | Experimental | Participants 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 Education | Active comparator | Participants 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.
Demand
Number of inquiries
Measured: Up to one year
Recruitment Success
Whether 30 participants will enroll and complete the 6-week study
Measured: Up to one year
Implementation practicality
Whether the interventions can be successfully administered remotely in this population
Measured: Up to one year
Acceptability
Comfort and tolerability ratings on a 0-100 scale
Measured: 6 weeks
Retention
Attrition Rate
Measured: 6 weeks
Adherence to Protocol
Percentage of participants who adhered to each intervention
Measured: 6 weeks
Secondary outcomes (4)
Use of Benzodiazepine Receptor Agonist medications
Frequency and amount used during the study
Measured: 6 weeks
Cessation of Benzodiazepine Receptor Agonist medication
Number of participants not taking Benzodiazepine medication by the end of the trial
Measured: 6 weeks
Baseline Urine Benzodiazepine Receptor Agonist Concentration
Concentration of Benzodiazepine metabolites in urine
Measured: Baseline
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.
- First posted9 Apr 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
- Investigators
- Ryan Bradley, ND,MPH, Principal investigator, National University of Natural Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely-delivered Yoga Nidra for Decreasing Use of BZRAs for Insomnia and Anxiety in Older Adults
- ClinicalTrials.gov ID
- NCT06353919
- Acronym / sponsor ID
- NUNM
- Keywords
- Yoga, Anxiety, Insomnia, Benzodiazepine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Nidra | Experimental | Other: Yoga NidraParticipants will practice 30 minutes of yoga nidra 3-5x's/week for 6 weeks |
| Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education | Active comparator | Other: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist EducationParticipants will review education material for 30 minutes at a time, 3-5x's/week for 6 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga NidraRecordings 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. | Other | Yoga Nidra |
| Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist EducationParticipants will be instructed to access excerpts from standardized and trusted materials through our online platform for 30 minutes, 3-5 times per week. | Other | Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education |
Primary outcome
Demand
Time frame: Up to one year
Number of inquiries
Recruitment Success
Time frame: Up to one year
Whether 30 participants will enroll and complete the 6-week study
Implementation practicality
Time frame: Up to one year
Whether the interventions can be successfully administered remotely in this population
Acceptability
Time frame: 6 weeks
Comfort and tolerability ratings on a 0-100 scale
Retention
Time frame: 6 weeks
Attrition Rate
Adherence to Protocol
Time frame: 6 weeks
Percentage of participants who adhered to each intervention
4 secondary outcomes
Use of Benzodiazepine Receptor Agonist medications
Time frame: 6 weeks
Cessation of Benzodiazepine Receptor Agonist medication
Time frame: 6 weeks
Baseline Urine Benzodiazepine Receptor Agonist Concentration
Time frame: Baseline
Close-out Urine Benzodiazepine Receptor Agonist Concentration
Time frame: Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bradley, ND,MPH principal investigator
National University of Natural Medicine
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.