Insomnia Due to Anxiety and FearNCT04571593
Remote Yoga Nidra for Anxiety and Sleep
A study testing Yoga Nidra in people with Insomnia Due to Anxiety and Fear, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The goal of this application is to collect survey data indicating the effects of a digital Yoga Nidra practice on anxiety and sleep during COVID-19. We will explore effects on momentary anxiousness, as well as on sleep. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia Due to Anxiety and Fear
- What is being tested?
- Yoga Nidra
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 14 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Can understand a recording in English while resting comfortably
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine, Helfgott Research Institute
Portland, Oregon, 97201
About this study
Official title: Digital Delivery of Yoga Nidra for Anxiety and Sleep: A Feasibility Study
The goal of this application is to collect survey data indicating the effects of a digital Yoga Nidra practice on anxiety and sleep during COVID-19. We will explore effects on momentary anxiousness, as well as on sleep. Participants will be consented through REDCap during the Yoga Nidra class, then asked to complete an intake form, a sleep questionnaire (composed of questions from the Post Sleep Questionnaire (PSQ)) and a pre/post State Trait Anxiety (STAI) Index, surrounding the practice. Participants will receive an email the next morning, inquiring about their sleep (~2 min survey), and again the following week, the morning of the Yoga Nidra class, in order to remind them about the weekly class offering and also to collect sleep data for a night that did not include pre-bed Yoga Nidra. We will additionally report feasibility measures including enrollment, retention, qualitative feedback, and challenges of using the digital platform. Using this data, we will gain valuable feasibility data for implementation of this type of mind-body practice using digital platforms. We will also gain important data on the effects of this practice on anxiety and sleep.
- Conditions
- Insomnia Due to Anxiety and Fear
- Being tested
- Yoga Nidra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga NidraBehavioural
The practice of Yoga Nidra, is a scripted and reproducible, guided meditation technique that promotes mental, emotional and physical relaxation while also facilitating the transition between waking and sleeping.
| Study group | Role | What they receive |
|---|---|---|
| Digital Yoga Nidra | Experimental | Participants will voluntarily complete a ~30-minute remote Yoga Nidra practice, synchronously (through Zoom Wednesdays at 10 pm ET) or asynchronously (through YouTube, using the Zoom recording, any time they like).
They may voluntarily repeat this practice as often as they like. Recordings are updated weekly, to reflect the ongoing Zoom class. Yoga Nidra scripts from Satyananda Saraswati's "Yoga Nidra" book (1976) are used for this class. Receives: Behavioral: Yoga Nidra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Momentary Anxiety
State Trait Anxiety (STAI-6) Short Form (scale 20 to 80, with higher scores indicating higher momentary anxiety)
Measured: Pre-intervention and immediately after the intervention
Change in Sleep Quality
Post Sleep Questionnaire (PSQ): six questions
Measured: Baseline (pre-intervention), 1 day (morning after intervention), and 2-6 days later (survey sent each Tuesday, to capture a night without Yoga Nidra)
Secondary outcomes (2)
Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey
Qualitative Feedback Survey (developed in-house)
Measured: Post-intervention (survey sent at 16 weeks)
Satisfaction as assessed by a Feedback Survey
Qualitative Feedback Survey (developed in-house)
Measured: Post-intervention (survey sent at 16-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start15 Apr 2020
- Primary completion5 Aug 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Anxiety and FearStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Sharpe, National University of Natural Medicine
- Investigators
- Erica M Sharpe, PhD, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571593
- Sponsor's protocol ID
- ESRB41320
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol, analysis and consent are shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Delivery of Yoga Nidra for Anxiety and Sleep: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04571593
- Acronym / sponsor ID
- ESRB41320
- Conditions
- Insomnia Due to Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 1 Oct 2020 (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 goal of this application is to collect survey data indicating the effects of a digital Yoga Nidra practice on anxiety and sleep during COVID-19. We will explore effects on momentary anxiousness, as well as on sleep. Participants will be consented through REDCap during the Yoga Nidra class, then asked to complete an intake form, a sleep questionnaire (composed of questions from the Post Sleep Questionnaire (PSQ)) and a pre/post State Trait Anxiety (STAI) Index, surrounding the practice. Participants will receive an email the next morning, inquiring about their sleep (~2 min survey), and again the following week, the morning of the Yoga Nidra class, in order to remind them about the weekly class offering and also to collect sleep data for a night that did not include pre-bed Yoga Nidra. We will additionally report feasibility measures including enrollment, retention, qualitative feedback, and challenges of using the digital platform. Using this data, we will gain valuable feasibility data for implementation of this type of mind-body practice using digital platforms. We will also gain important data on the effects of this practice on anxiety and sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Yoga Nidra | Experimental | Behavioral: Yoga NidraParticipants will voluntarily complete a ~30-minute remote Yoga Nidra practice, synchronously (through Zoom Wednesdays at 10 pm ET) or asynchronously (through YouTube, using the Zoom recording, any time they like). They may voluntarily repeat this practice as often as they like. Recordings are updated weekly, to reflect the ongoing Zoom class. Yoga Nidra scripts from Satyananda Saraswati's "Yoga Nidra" book (1976) are used for this class. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults
- Can understand a recording in English while resting comfortably
Key exclusion criteria (0 listed)
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 NidraThe practice of Yoga Nidra, is a scripted and reproducible, guided meditation technique that promotes mental, emotional and physical relaxation while also facilitating the transition between waking and sleeping. | Behavioural | Digital Yoga Nidra |
Primary outcome
Change in Momentary Anxiety
Time frame: Pre-intervention and immediately after the intervention
State Trait Anxiety (STAI-6) Short Form (scale 20 to 80, with higher scores indicating higher momentary anxiety)
Change in Sleep Quality
Time frame: Baseline (pre-intervention), 1 day (morning after intervention), and 2-6 days later (survey sent each Tuesday, to capture a night without Yoga Nidra)
Post Sleep Questionnaire (PSQ): six questions
2 secondary outcomes
Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey
Time frame: Post-intervention (survey sent at 16 weeks)
Satisfaction as assessed by a Feedback Survey
Time frame: Post-intervention (survey sent at 16-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Protocol, analysis and consent are shared.
Related trials for Insomnia Due to Anxiety and Fear
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Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
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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.
Erica M Sharpe, PhD principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Nidra in people with Insomnia Due to Anxiety and Fear, run by National University of Natural Medicine at 1 site in United States.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Momentary Anxiety (time frame: Pre-intervention and immediately after the intervention). The study lists 2 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 18 Nov 2023.