Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Closer Look at Yoga Nidra: Sleep Lab Analyses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685227
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
Oregon Health and Science University
University of Manitoba
Information provided by (Responsible Party):
Erica Sharpe, National University of Natural Medicine

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Electroencephalography Electrocardiography Respiratory Rate Surveys and Questionnaires Other: Yoga Nidra Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Closer Look at Yoga Nidra: Sleep Lab Analyses
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : March 10, 2019
Actual Study Completion Date : March 10, 2019

Arm Intervention/treatment
No Intervention: Control
Participant will lie quietly for 90 minutes. They will be allowed to sleep.
Experimental: Yoga Nidra
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.
Other: Yoga Nidra
This is a mind/body technique. Specifically, it is a guided meditation, performed while lying down.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in time to sleep onset [ Time Frame: 90 minutes ]
    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.

  2. Change in heart rate variability (HRV) parameters [ Time Frame: 90 minutes ]
    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.

  3. Change in respiration rate [ Time Frame: 90 minutes ]
    Average change in respiratory rate (visit 1 to visit 2) will be compared for intervention and control groups.

  4. Feasibility: Credibility of Intervention [ Time Frame: Rating will occur immediately after their visit ]
    After the intervention, participants will rate perceived credibility of the intervention for its use in producing sleep.

  5. Feasibility: Acceptability of Intervention [ Time Frame: Seven months ]
    Acceptability will be determined using recruitment and dropout rates



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Insomnia severity index (ISI) score 8-21 (subthreshold to moderately severe clinical insomnia)
  • Can understand a recording in English

Exclusion Criteria:

  • 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
  • smoking
  • stimulant use
  • shift work
  • fibromyalgia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685227


Locations
Layout table for location information
United States, Oregon
National University of Natural Medicine, Helfgott Research Institute
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National University of Natural Medicine
Oregon Health and Science University
University of Manitoba
Investigators
Layout table for investigator information
Principal Investigator: Erica Sharpe, PhD National University of Natural Medicine (NUNM)
  Study Documents (Full-Text)

Documents provided by Erica Sharpe, National University of Natural Medicine:
Layout table for additonal information
Responsible Party: Erica Sharpe, Research Investigator/BRIDG Program Fellow, National University of Natural Medicine
ClinicalTrials.gov Identifier: NCT03685227    
Other Study ID Numbers: ES62018
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erica Sharpe, National University of Natural Medicine:
Yoga Nidra
Electroencephalography
Electrocardiography
Respiratory rate