NCT03685227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

September 21, 2018

Last Update Submit

June 13, 2019

Conditions

ElectroencephalographyElectrocardiographyRespiratory RateSurveys and Questionnaires

Keywords

Yoga NidraElectroencephalographyElectrocardiographyRespiratory rate

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (5)

  • Change in time to sleep onset

    90 minutes

  • Change in heart rate variability (HRV) parameters

    90 minutes

  • Change in respiration rate

    90 minutes

  • Feasibility: Credibility of Intervention

    Rating will occur immediately after their visit

  • Feasibility: Acceptability of Intervention

    Seven months

Study Arms (2)

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.

Other: Yoga Nidra

Interventions

Yoga NidraOTHER

This is a mind/body technique. Specifically, it is a guided meditation, performed while lying down.

Yoga Nidra

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Natural Medicine, Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

Related Publications (1)

  • 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.

    PMID: 36731199DERIVED

Study Officials

  • Erica Sharpe, PhD

    National University of Natural Medicine (NUNM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator/BRIDG Program Fellow

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 26, 2018

Study Start

September 10, 2018

Primary Completion

March 10, 2019

Study Completion

March 10, 2019

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

US(1)