The Effect of Yoga Self-Practice on Sleep Disturbance

Yoga Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04719039
• Other study ID #: PSY014
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: Chinese University of Hong Kong
• Contact: Tina Chan
• Phone: +852 3943 6575
• Email: 1009613291[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• 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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, intervention period (8 weeks), immediate and 4-week post-intervention
Primary	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.	Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Primary	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.	Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Primary	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.	Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Primary	Sleep Diary - Change in total wake time (TWT)	The standardized sleep diary records wake time to measure sleep disturbance.	Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Primary	Sleep Diary - Change in total sleep time (TST)	The standardized sleep diary records wake time to measure sleep disturbance.	Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Primary	Sleep Diary - Change in sleep efficiency (SE)	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	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.	Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Secondary	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.	Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Secondary	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.	Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Secondary	Change in Credibility-Expectancy Questionnaire (CEQ)	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