A Closer Look at Yoga Nidra: Sleep Lab Analyses

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.

Study Overview

• Status: Completed
• Conditions: Electrocardiography; Electroencephalography; Respiratory Rate; Surveys and Questionnaires
• Intervention / Treatment: Other: Yoga Nidra

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • National University of Natural Medicine, Helfgott Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	90 minutes
Change in respiration rate	Average change in respiratory rate (visit 1 to visit 2) will be compared for intervention and control groups.	90 minutes
Feasibility: Credibility of Intervention	After the intervention, participants will rate perceived credibility of the intervention for its use in producing sleep.	Rating will occur immediately after their visit
Feasibility: Acceptability of Intervention	Acceptability will be determined using recruitment and dropout rates	Seven months

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Collaborators: University of Manitoba; Oregon Health and Science University
• Investigators: Principal Investigator: Erica Sharpe, PhD, National University of Natural Medicine (NUNM)

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): March 10, 2019

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Electroencephalography; Electrocardiography; Yoga Nidra; Respiratory rate
• Other Study ID Numbers: ES62018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No