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The Effect of Yoga Self-Practice on Sleep Disturbance

Primary Purpose

Yoga

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Restorative Yoga Internvention
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Yoga focused on measuring Insomnia, Yoga, Mindful breathing

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Group

Waitlist Control Group

Arm Description

Restorative Yoga intervention

Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment

Outcomes

Primary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI)
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.
Change in Insomnia Severity Index (ISI)
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.
Sleep Diary - Change in sleep-Onset latency (SOL)
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.
Sleep Diary - Change in wake after sleep onset (WASO)
The standardized sleep diary records the periods of wakefulness occurring after defined sleep onset on a daily basis, reflecting sleep fragmentation.
Sleep Diary - Change in total wake time (TWT)
The standardized sleep diary records wake time to measure sleep disturbance.
Sleep Diary - Change in total sleep time (TST)
The standardized sleep diary records wake time to measure sleep disturbance.
Sleep Diary - Change in sleep efficiency (SE)
The Sleep efficiency is measured in percentage by dividing TST by total time in bed.

Secondary Outcome Measures

Change in Hospital Anxiety and Depression Scale (HADS-14)
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.
Change in Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Change in Short Form (Six-Dimension) Health Survey (SF-6D)
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.
Change in Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.

Full Information

First Posted
January 14, 2021
Last Updated
January 19, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04719039
Brief Title
The Effect of Yoga Self-Practice on Sleep Disturbance
Official Title
The Effect of Restorative Yoga Self-Practice on Sleep Disturbance: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yoga
Keywords
Insomnia, Yoga, Mindful breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
Restorative Yoga intervention
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Intervention Type
Behavioral
Intervention Name(s)
Restorative Yoga Internvention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline, intervention period (8 weeks), immediate and 4-week post-intervention
Title
Change in Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Title
Sleep Diary - Change in sleep-Onset latency (SOL)
Description
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.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Title
Sleep Diary - Change in wake after sleep onset (WASO)
Description
The standardized sleep diary records the periods of wakefulness occurring after defined sleep onset on a daily basis, reflecting sleep fragmentation.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Title
Sleep Diary - Change in total wake time (TWT)
Description
The standardized sleep diary records wake time to measure sleep disturbance.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Title
Sleep Diary - Change in total sleep time (TST)
Description
The standardized sleep diary records wake time to measure sleep disturbance.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Title
Sleep Diary - Change in sleep efficiency (SE)
Description
The Sleep efficiency is measured in percentage by dividing TST by total time in bed.
Time Frame
Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS-14)
Description
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.
Time Frame
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Title
Change in Multidimensional Fatigue Inventory (MFI-20)
Description
The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Time Frame
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Title
Change in Short Form (Six-Dimension) Health Survey (SF-6D)
Description
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.
Time Frame
Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Title
Change in Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
Baseline, immediately after the 8-week intervention, and 4-week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hong Kong residents aged 18-59 years; Cantonese language fluency; A global Insomnia Severity Index (ISI) score of 10 or higher; No yoga experience within the 6 months before the study; and A willingness to provide informed consent and comply with the trial protocol. Exclusion Criteria: Participants were excluded if they are pregnant; are having unsafe conditions and are not recommended for restorative yoga by physicians; have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the yoga practice; have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders; and are shift workers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Chan
Phone
+852 3943 6575
Email
1009613291@link.cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

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The Effect of Yoga Self-Practice on Sleep Disturbance

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