YogaNCT04719039
The Effect of Yoga Self-Practice on Sleep Disturbance
A study testing Restorative Yoga Internvention in people with Yoga, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Yoga
- What is being tested?
- Restorative Yoga Internvention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2021to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Yoga
- Being tested
- Restorative Yoga Internvention
- Keywords
- Insomnia, Yoga, Mindful breathing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative Yoga InternventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Restorative Yoga intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
Secondary outcomes (4)
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.
Measured: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
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.
Measured: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
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.
Measured: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Change in Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Measured: Baseline, immediately after the 8-week intervention, and 4-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719039
- Sponsor's protocol ID
- PSY014
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Restorative Yoga Self-Practice on Sleep Disturbance: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04719039
- Acronym / sponsor ID
- PSY014
- Conditions
- Yoga
- Keywords
- Insomnia, Yoga, Mindful breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Restorative Yoga InternventionRestorative Yoga intervention |
| Waitlist Control Group | No intervention | –Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorative Yoga InternventionParticipants 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. | Behavioural | Yoga Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS-14)
Time frame: 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
Change in Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorative Yoga Internvention in people with Yoga, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tina Chan (+852 3943 6575, 1009613291@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, intervention period (8 weeks), immediate and 4-week post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.