ElectroencephalographyNCT03685227
A Closer Look at Yoga Nidra: Sleep Lab Analyses
A study testing Yoga Nidra in people with Electroencephalography and Electrocardiography, run by National University of Natural Medicine at 1 site in United States.
Trial summary
This study is being conducted in order to understand more about how the body responds to a mind/body practice called yoga nidra. Results from this study will be used to inform the design of future studies that investigate the effects of yoga nidra on sleep quality and insomnia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Electroencephalography, Electrocardiography, Respiratory Rate
- What is being tested?
- Yoga Nidra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 10 Mar 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Insomnia severity index (ISI) score 8-21 (subthreshold to moderately severe clinical insomnia)
- Can understand a recording in English
Who cannot join
- prescription sleeping medications
- regular mind/body practice within last 6 months
- diagnosed depression (or Patient Health Questionnaire (PHQ-2 into PHQ-9) score above 10)
- diagnosed sleep apnea (or STOP-BANG Sleep Apnea Questionnaire score of 3 or more)
- excessive alcohol use
- cannabis use
Show all 10Show fewer
- smoking
- stimulant use
- shift work
- fibromyalgia
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
This study is being conducted in order to understand more about how the body responds to a mind/body practice called yoga nidra. Results from this study will be used to inform the design of future studies that investigate the effects of yoga nidra on sleep quality and insomnia.
Yoga nidra is a simple guided meditation technique that involves lying still on a mattress while listening to a voice. Participants will follow simple instructions that involve becoming aware of their body and breath, as well as various memories, emotions, and images. This practice is not religious in nature. The investigators do not believe it will conflict with any religious beliefs. The goal of this practice is to help get rid of mental, physical and emotional tensions.
Read the detailed description
This clinical trial explores the physiological effects of yoga nidra and its connection to sleep. The investigators will measure patterns in brainwave activity, respiration and heart rate variability using EEG, and two wireless devices: the Spire® breath monitor and the Bodyguard® HRV monitor. This study will also address feasibility questions related to credibility and acceptability, using self-report surveys, drop-out rates, and participant feedback. Twenty-two participants will be recruited using digital and paper advertisements throughout Portland and the National University of Natural Medicine (NUNM). Interested individuals will contact the study coordinator, and then complete a screening call. During this telephone screening, the study coordinator will ask general questions and use standardized surveys to exclude participants based on inclusion/exclusion criteria. Prospective participants who pass the telephone screening will then be invited for two visits to the Helfgott Research Institute. Each visit will involve informed consent, followed by the completion of two eligibility surveys, and several intake questionnaires. The measurement periods will involve: 10 minutes of baseline data collection, 30 minutes of lying quietly or listening to a recording of yoga nidra, and then 1 hour of resting comfortably. Participants will be allowed to fall asleep during this time and will be left alone in the room with the lights out during the entire intervention (after the first 10 minutes of baseline data collection). When finished, participants will complete a few short questionnaires before their departure. The first visit will involve lying quietly as a baseline control. At the second visit, half of the population will be randomly selected to do yoga nidra and half will complete the baseline control measurements again.
- Being tested
- Yoga Nidra
- Keywords
- Yoga Nidra, Electroencephalography, Electrocardiography, Respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga NidraOther
This is a mind/body technique. Specifically, it is a guided meditation, performed while lying down.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participant will lie quietly for 90 minutes. They will be allowed to sleep. |
| Yoga Nidra | Experimental | Participant will practice yoga nidra (using a recording) during the first 30 minutes of the 90 minute measurement period. Then they will be allowed to sleep. Receives: Other: Yoga Nidra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG power (uV^2/Hz) of alpha brainwaves (defined by frequencies between 8-12 Hz) measured from the occipital region of the scalp.
Average change in alpha power (from visit 1 to visit 2) will be compared for intervention and control groups. Other frequency bands (delta, beta, and theta) will be measured as well. EEG measurements will be collected from the F3, C3, and O1 locations on the scalp.
Measured: 90 minutes
Secondary outcomes (5)
Change in time to sleep onset
Average change in time to sleep onset (SOL) from visit 1 to visit 2, will be compared for intervention and control groups. The EEG montage follows American Academy of Sleep Medicine (AASM) guidelines for sleep measurement, and includes sensors placed in the following locations: ChinZ, Chin1, E1, E2, F3, C3, and O1, with (contralateral) reference and ground electrodes clipped onto the right and left earlobes, respectively.
Measured: 90 minutes
Change in heart rate variability (HRV) parameters
The average change (visit 1 to visit 2) in two HRV parameters (root mean square of successive differences between normal-to-normal intervals (RMSSD, ms); and high frequency power (HF, ms^2)) will be compared for intervention and control groups.
Measured: 90 minutes
Change in respiration rate
Average change in respiratory rate (visit 1 to visit 2) will be compared for intervention and control groups.
Measured: 90 minutes
Feasibility: Credibility of Intervention
After the intervention, participants will rate perceived credibility of the intervention for its use in producing sleep.
Measured: Rating will occur immediately after their visit
Feasibility: Acceptability of Intervention
Acceptability will be determined using recruitment and dropout rates
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start10 Sep 2018
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalographyStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, University of Manitoba
- Responsible party
- Principal investigator, Erica Sharpe, National University of Natural Medicine
- Investigators
- Erica Sharpe, PhD, Principal investigator, National University of Natural Medicine (NUNM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685227
- Sponsor's protocol ID
- ES62018
- Status last verified
- Jun 2019
- First submitted
- 21 Sep 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sharpe E, Butler MP, Clark-Stone J, Soltanzadeh R, Jindal R, Hanes D, Bradley R. A closer look at yoga nidra- early randomized sleep lab investigations. J Psychosom Res. 2023 Mar;166:111169. doi: 10.1016/j.jpsychores.2023.111169. Epub 2023 Jan 29.
PubMed 36731199
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Closer Look at Yoga Nidra: Sleep Lab Analyses
- ClinicalTrials.gov ID
- NCT03685227
- Acronym / sponsor ID
- ES62018
- Keywords
- Yoga Nidra, Electroencephalography, Electrocardiography, Respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, University of Manitoba
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 26 Sep 2018 (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.
This study is being conducted in order to understand more about how the body responds to a mind/body practice called yoga nidra. Results from this study will be used to inform the design of future studies that investigate the effects of yoga nidra on sleep quality and insomnia.
Yoga nidra is a simple guided meditation technique that involves lying still on a mattress while listening to a voice. Participants will follow simple instructions that involve becoming aware of their body and breath, as well as various memories, emotions, and images. This practice is not religious in nature. The investigators do not believe it will conflict with any religious beliefs. The goal of this practice is to help get rid of mental, physical and emotional tensions.
Detailed description
This clinical trial explores the physiological effects of yoga nidra and its connection to sleep. The investigators will measure patterns in brainwave activity, respiration and heart rate variability using EEG, and two wireless devices: the Spire® breath monitor and the Bodyguard® HRV monitor. This study will also address feasibility questions related to credibility and acceptability, using self-report surveys, drop-out rates, and participant feedback. Twenty-two participants will be recruited using digital and paper advertisements throughout Portland and the National University of Natural Medicine (NUNM). Interested individuals will contact the study coordinator, and then complete a screening call. During this telephone screening, the study coordinator will ask general questions and use standardized surveys to exclude participants based on inclusion/exclusion criteria. Prospective participants who pass the telephone screening will then be invited for two visits to the Helfgott Research Institute. Each visit will involve informed consent, followed by the completion of two eligibility surveys, and several intake questionnaires. The measurement periods will involve: 10 minutes of baseline data collection, 30 minutes of lying quietly or listening to a recording of yoga nidra, and then 1 hour of resting comfortably. Participants will be allowed to fall asleep during this time and will be left alone in the room with the lights out during the entire intervention (after the first 10 minutes of baseline data collection). When finished, participants will complete a few short questionnaires before their departure. The first visit will involve lying quietly as a baseline control. At the second visit, half of the population will be randomly selected to do yoga nidra and half will complete the baseline control measurements again.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participant will lie quietly for 90 minutes. They will be allowed to sleep. |
| Yoga Nidra | Experimental | Other: Yoga NidraParticipant will practice yoga nidra (using a recording) during the first 30 minutes of the 90 minute measurement period. Then they will be allowed to sleep. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Insomnia severity index (ISI) score 8-21 (subthreshold to moderately severe clinical insomnia)
- Can understand a recording in English
Key exclusion criteria (10 listed)
- prescription sleeping medications
- regular mind/body practice within last 6 months
- diagnosed depression (or Patient Health Questionnaire (PHQ-2 into PHQ-9) score above 10)
- diagnosed sleep apnea (or STOP-BANG Sleep Apnea Questionnaire score of 3 or more)
- excessive alcohol use
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 NidraThis is a mind/body technique. Specifically, it is a guided meditation, performed while lying down. | Other | Yoga Nidra |
Primary outcome
Change in EEG power (uV^2/Hz) of alpha brainwaves (defined by frequencies between 8-12 Hz) measured from the occipital region of the scalp.
Time frame: 90 minutes
Average change in alpha power (from visit 1 to visit 2) will be compared for intervention and control groups. Other frequency bands (delta, beta, and theta) will be measured as well. EEG measurements will be collected from the F3, C3, and O1 locations on the scalp.
5 secondary outcomes
Change in time to sleep onset
Time frame: 90 minutes
Change in heart rate variability (HRV) parameters
Time frame: 90 minutes
Change in respiration rate
Time frame: 90 minutes
Feasibility: Credibility of Intervention
Time frame: Rating will occur immediately after their visit
Feasibility: Acceptability of Intervention
Time frame: Seven months
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 17 Jun 2019.
- Derived from this study: PubMed 36731199Sharpe E, Butler MP, Clark-Stone J, Soltanzadeh R, Jindal R, Hanes D, Bradley R. A closer look at yoga nidra- early randomized sleep lab investigations. J Psychosom Res. 2023 Mar;166:111169. doi: 10.1016/j.jpsychores.2023.111169. Epub 2023 Jan 29.
- Individual participant dataSharing planned: Undecided
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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 Sharpe, PhD principal investigator
National University of Natural Medicine (NUNM)
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 Electroencephalography and Electrocardiography, 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 10 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 17 Jun 2019. 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 EEG power (uV^2/Hz) of alpha brainwaves (defined by frequencies between 8-12 Hz) measured from the occipital region of the scalp. (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685227, which also lists 1 linked publication.
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 17 Jun 2019.