A Closer Look at Yoga Nidra: Sleep Lab Analyses

Electroencephalography Clinical Trial

Official title:

A Closer Look at Yoga Nidra: Sleep Lab Analyses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685227
• Other study ID #: ES62018
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: June 2019
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 10, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrocardiography
• Electroencephalography
• Respiratory Rate
• Surveys and Questionnaires

Intervention

Other:
• Yoga Nidra
This is a mind/body technique. Specifically, it is a guided meditation, performed while lying down.

Locations

Country	Name	City	State
United States	National University of Natural Medicine, Helfgott Research Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
National University of Natural Medicine	Oregon Health and Science University, University of Manitoba

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in respiration rate	Average change in respiratory rate (visit 1 to visit 2) will be compared for intervention and control groups.	90 minutes
Secondary	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
Secondary	Feasibility: Acceptability of Intervention	Acceptability will be determined using recruitment and dropout rates	Seven months