The Effect of Yoga Self-Practice on Sleep Disturbance

NCT04719039 | Unknown

• 1 other identifier: PSY014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Yoga

Keywords

Insomnia; Yoga; Mindful breathing

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in Hospital Anxiety and Depression Scale (HADS-14)

  Baseline, immediately after the 8-week intervention, and 4-week post-intervention

• Change in Multidimensional Fatigue Inventory (MFI-20)

  Baseline, immediately after the 8-week intervention, and 4-week post-intervention

• Change in Short Form (Six-Dimension) Health Survey (SF-6D)

  Baseline, immediately after the 8-week intervention, and 4-week post-intervention

• Change in Credibility-Expectancy Questionnaire (CEQ)

  Baseline, immediately after the 8-week intervention, and 4-week post-intervention

Study Arms (2)

Yoga Group

EXPERIMENTAL

Restorative Yoga intervention

Behavioral: Restorative Yoga Internvention

Waitlist Control Group

NO INTERVENTION

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

Interventions

Restorative Yoga Internvention BEHAVIORAL

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.

Yoga Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Tina Chan

CONTACT

+852 3943 6575; 1009613291@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

HK (1)