The Effect of Yoga Self-Practice on Sleep Disturbance

January 19, 2021 updated by: Fiona YY Ho, Chinese University of Hong Kong

The Effect of Restorative Yoga Self-Practice on Sleep Disturbance: A Pilot Randomized Controlled Trial

The study will examine the effect of Restorative Yoga self-practice on sleep disturbance in the Chinese adult population. Restorative Yoga is a relaxation-focused yoga style which includes a series of static stretching poses and mindful breathing. Existing literature has demonstrated that face-to-face yoga sessions of different types are effective in improving sleep disturbance and reducing the severity of insomnia. There were pilot studies conducted on the effect of yoga on cancer patients' sleep quality, but research that focuses on insomnia population is rare (Wang et al., 2020). In addition, there is very limited research on the effectiveness of self-practice without the presence of a yoga instructor. Given the social distancing policy under COVID-19 and the need to stay home, this study can shed light on whether self-practice at home can be an effective alternative to face-to-face yoga sessions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a pilot randomized controlled trial on the effectiveness of restorative yoga self-practice for sleep disturbance. Prior to all study procedures, online informed consent (with phone support) will be obtained from potential participants. Around 30 eligible participants will be randomly assigned to either the yoga group (intervention group) or the waitlist control group in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.

Participants in the intervention group will receive links to two 60-min videos per week for 8 consecutive weeks. Each video will include a yoga practice guided by a certified yoga instructor. The intervention group is required to perform the yoga practice at least two times per week. If preferred, they can do additional sessions with the videos and record their total hours of self-practice. The waitlist control group will receive the video links subsequent to the 8-week study. The intervention group will complete a set of online questionnaires before the intervention commences, weekly during the intervention period, immediately after the intervention, and 4 weeks after the intervention. The waitlist control group will complete the same set of online questionnaires before the intervention commences and immediately after 8-week intervention period has ended.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Hong Kong residents aged 18-59 years;
  2. Cantonese language fluency;
  3. A global Insomnia Severity Index (ISI) score of 10 or higher;
  4. No yoga experience within the 6 months before the study; and
  5. A willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

Participants were excluded if they

  1. are pregnant;
  2. are having unsafe conditions and are not recommended for restorative yoga by physicians;
  3. have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the yoga practice;
  4. have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders; and
  5. are shift workers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Group
Restorative Yoga intervention
Behavioral: Restorative Yoga Internvention
Participants in the intervention group will receive links to two 60-min videos per week for 8 consecutive weeks. Each video will include a yoga practice guided by a certified yoga instructor. The intervention group is required to perform the yoga practice at least two times per week. If preferred, they can do additional sessions with the videos and record their total hours of self-practice.
No Intervention: Waitlist Control Group
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, intervention period (8 weeks), immediate and 4-week post-intervention

The PSQI-19 is a 19-item questionnaire used for measuring and identifying quality of sleep.

It provides a measure of global sleep quality, including sleep latency, sleep duration, habitual sleep efficiency and sleep disturbances.
Baseline, intervention period (8 weeks), immediate and 4-week post-intervention
Change in Insomnia Severity Index (ISI)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Sleep Diary - Change in sleep-Onset latency (SOL)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records the length of time that it takes to accomplish the transition from full wakefulness to sleep on a daily basis.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Sleep Diary - Change in wake after sleep onset (WASO)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records the periods of wakefulness occurring after defined sleep onset on a daily basis, reflecting sleep fragmentation.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Sleep Diary - Change in total wake time (TWT)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records wake time to measure sleep disturbance.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Sleep Diary - Change in total sleep time (TST)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records wake time to measure sleep disturbance.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Sleep Diary - Change in sleep efficiency (SE)
Time Frame: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The Sleep efficiency is measured in percentage by dividing TST by total time in bed.
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hospital Anxiety and Depression Scale (HADS-14)
Time Frame: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively. Each item is rated on a 4-point-scale (0-3) by the participant. The greater the score, the more psychologically distressed the respondent is.
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Change in Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Change in Short Form (Six-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Change in Credibility-Expectancy Questionnaire (CEQ)
Time Frame: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Baseline, immediately after the 8-week intervention, and 4-week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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