Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353919
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-11-14
Brief Title:
Remote Yoga Nidra for Deprescribing BZRAs
Sponsor:
National University of Natural Medicine
Organization:
National University of Natural Medicine
Study Overview
Official Title:
Remotely-delivered Yoga Nidra for Decreasing Use of BZRAs for Insomnia and Anxiety in Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 societys 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 insomniaanxiety 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None