InsomniaYOGiNCT05723211
The Yoga and Insomnia Study
A study testing Vinyasa yoga group in people with Insomnia and Insomnia, Psychophysiological, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of our study is to examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes in adults with insomnia symptoms. This study will examine the following aims: To examine the effects of a 4-week vinyasa yoga program compared to a non-active control condition on subjective… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Insomnia, Insomnia, Psychophysiological, Sleep Disorder
- What is being tested?
- Vinyasa yoga group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 26 Jun 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Insomnia Severity Index (ISI) score ≥ 10
- Age 18-55 years
- Insufficiently active defined by the Stanford Leisure-Time Activity Categorical Item responses below public health physical activity guidelines
Who cannot join
- Self-reported regular vinyasa and/or power yoga practice defined as ≥ 60 minutes/week within the past 3 months
- Diagnosed medical condition requiring medical clearance defined as a 'yes' response on follow-up questions pertaining to a present medical condition(s) via Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Physical limitations and/or mobility restriction that would interfere with the ability to perform yoga defined as a 'yes' response on the PAR-Q+; self-reported lack of treatment for a major psychiatric disorder via medical history survey
- High risk for obstructive sleep apnea defined as score ≥ 5 via STOP-Bang score
- Self-reported current pregnancy or planning to become pregnant within the next 3 months
- Overnight shift work defined as regularly working any time between 00:00 and 06:00 am
- Self-reported current treatment for insomnia via medical history survey
- Medications that may affect heart rate during exercise via self-report on the medical history survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: The Effects of a 4-week Vinyasa Yoga Program on Sleep and Cardiovascular Health in Adults With Insomnia Symptoms: A Randomized Controlled Trial
The purpose of our study is to examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes in adults with insomnia symptoms. This study will examine the following aims:
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control condition on subjective and objective sleep-related outcomes in adults who report insomnia symptoms.
Read more
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control on cardiovascular health.
To examine the effects of a single session of vinyasa yoga compared to a non-active control condition on sleep- and cardiovascular-related outcomes collected overnight.
Researchers will compare the yoga group and the non-active control group to see if there are any improvements in sleep and cardiovascular health.
Read the detailed description
This study will examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes using a randomized parallel group design. Following baseline assessments, participants will be randomly assigned into one of the two experimental conditions (i.e., vinyasa yoga, non-active control condition) based on stratification by sex (i.e., male, female) in a 1:1 ratio.
All groups will complete an initial in-person experimental session during the early evening: those in the vinyasa yoga group will be guided through a supervised vinyasa yoga session and those in the non-active control group will complete a quiet rest session. Participants will be provided an Actiwatch and heart rate monitor to measure acute experimental effects on sleep and nocturnal heart rate variability.
Following the initial supervised session, those in the vinyasa yoga intervention will be provided with a yoga mat and a standardized video and asked to practice 3 times per week for 4 weeks; compliance will be monitored by an online log. The non-active control group will not receive any yoga intervention and will be asked to avoid starting a new exercise routine.
Following the 4-week intervention, all participants will complete post-intervention sleep and cardiovascular assessments following the same procedures used at baseline.
- Conditions
- Insomnia, Insomnia, Psychophysiological, Sleep Disorder
- Being tested
- Vinyasa yoga group, Non-active control group
- Keywords
- sleep, cardiovascular, insomnia, yoga, physical activity
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinyasa yoga groupBehavioural
Participants will be instructed to perform a pre-recorded 60-minute vinyasa yoga session 3 times a week for 4 weeks.
Non-active control groupOther
Participants will be instructed to sit quietly for 60 minutes and watch a nature documentary during this time. The participants will be asked to maintain their current lifestyle habits and refrain from starting a new exercise and/or yoga program.
| Study group | Role | What they receive |
|---|---|---|
| Vinyasa yoga group | Experimental | The vinyasa yoga practice will be 60 minutes in duration and includes standing, seated, and supine postures in the following sequences in order: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series. Participants will be instructed to follow the cues provided in the video and to take any necessary modifications to make each yoga pose more accessible. Vinyasa yoga intervention level 1 will be performed for week 1, level 2 will be performed for week 2, and level 3 will be performed for weeks 3 and 4 of the intervention. Receives: Behavioral: Vinyasa yoga group |
| Non-active control group | Other | The participants in the non-active control condition will serve as a control group. They will be asked to maintain their current lifestyle habits and refrain from starting a new exercise and/or yoga program. A staff member will contact each participant weekly to check in and review any changes to their medical history or activity levels. Receives: Other: Non-active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Insomnia Severity Index is a 7-item self-report questionnaire that assesses the severity of the nighttime and daytime impact of insomnia symptoms. Each question is rated on a 5-point Likert scale, with a score of 0 indicating 'no problem' and 4 indicating 'very severe'. The total score is obtained by summing the scores of the individual items ranging from 0 to 28; a higher score indicates more severe insomnia symptoms.
Measured: Baseline, post-intervention (4 weeks)
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD)
Nocturnal root mean square of successive difference between normal heartbeats will be assessed for 1 night with a Polar heart rate monitor strap; an increase indicates better cardiovascular health
Measured: Baseline, post-intervention (4 weeks)
Secondary outcomes (10)
Change from baseline sleep efficiency at 4 weeks
Actigraphy-assessed sleep efficiency, averaged over 7 nights
Measured: Baseline, post-intervention (4 weeks)
Change from baseline total sleep time at 4 weeks
Actigraphy-assessed total sleep time, averaged over 7 nights
Measured: Baseline, post-intervention (4 weeks)
Change from baseline resting systolic blood pressure at 4 weeks
Resting systolic blood pressure will be measured using an automated blood pressure system in the seated position
Measured: Baseline, post-intervention (4 weeks)
Change from baseline resting heart rate at 4 weeks
Resting heart rate will be measured using a automated blood pressure system in the seated position
Measured: Baseline, post-intervention (4 weeks)
Change from baseline resting carotid-femoral pulse wave velocity
Pulse wave velocity is a measure of arterial stiffness
Measured: Baseline, post-intervention (4 weeks)
Change from baseline quality of sleep
Sleep quality will be assessed using a sleep diary on a scale of 'very poor' to 'very good'
Measured: Baseline, post-intervention (4 weeks)
Change from baseline in Epworth Sleepiness Scale
Daytime sleepiness will be measured using the Epworth Sleepiness Scale (ESS). It is a brief 8-item questionnaire asking individuals to rate the likelihood of falling asleep on a 4-point scale (0 indicating 'would never doze off' and '3' indicating 'high chance of dozing') across eight situations that occur in daily life. The scores are summed for a total score that ranges from 0-24; a score ≥ 10 indicating clinically significant daytime sleepiness.
Measured: Baseline, post-intervention (4 weeks)
Change from baseline in Ford Insomnia Response to Stress Test
Sleep reactivity, the stress-related vulnerability to experience sleep disturbances under stressful conditions will be measured by the Ford Insomnia Response to Stress Test; higher scores are associated with more sleep difficulties and elevated physiological stress.
Measured: Baseline, post-intervention (4 weeks)
Change from baseline in Patient Health Questionnaire
Depression severity will be measured using the Patient Health Questionnaire which assess depressive symptoms over the past two weeks; a score > 10 indicates moderate severity depression symptoms.
Measured: Baseline, post-intervention ( 4 weeks)
Change from baseline in Generalized Anxiety Disorder-7 Questionnaire
Anxiety severity will be measured using the Generalized Anxiety Disorder Questionnaire which assess symptoms over the past two weeks; a score ≥ 10 detects generalized anxiety disorder.
Measured: Baseline, post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Mar 2023
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Cheruka, University of Pittsburgh
- Investigators
- Caitlin A. Cheruka, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723211
- Sponsor's protocol ID
- STUDY22110168
- Acronym
- YOGi
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified data that are relevant to the primary aims of the study will be provided by external researchers along with a relevant data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 4-week Vinyasa Yoga Program on Sleep and Cardiovascular Health in Adults With Insomnia Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05723211
- Acronym / sponsor ID
- YOGi / STUDY22110168
- Conditions
- Insomnia, Insomnia, Psychophysiological, Sleep Disorder
- Keywords
- sleep, cardiovascular, insomnia, yoga, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 10 Feb 2023 (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 purpose of our study is to examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes in adults with insomnia symptoms. This study will examine the following aims:
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control condition on subjective and objective sleep-related outcomes in adults who report insomnia symptoms.
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control on cardiovascular health.
To examine the effects of a single session of vinyasa yoga compared to a non-active control condition on sleep- and cardiovascular-related outcomes collected overnight.
Researchers will compare the yoga group and the non-active control group to see if there are any improvements in sleep and cardiovascular health.
Detailed description
This study will examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes using a randomized parallel group design. Following baseline assessments, participants will be randomly assigned into one of the two experimental conditions (i.e., vinyasa yoga, non-active control condition) based on stratification by sex (i.e., male, female) in a 1:1 ratio.
All groups will complete an initial in-person experimental session during the early evening: those in the vinyasa yoga group will be guided through a supervised vinyasa yoga session and those in the non-active control group will complete a quiet rest session. Participants will be provided an Actiwatch and heart rate monitor to measure acute experimental effects on sleep and nocturnal heart rate variability.
Following the initial supervised session, those in the vinyasa yoga intervention will be provided with a yoga mat and a standardized video and asked to practice 3 times per week for 4 weeks; compliance will be monitored by an online log. The non-active control group will not receive any yoga intervention and will be asked to avoid starting a new exercise routine.
Following the 4-week intervention, all participants will complete post-intervention sleep and cardiovascular assessments following the same procedures used at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinyasa yoga group | Experimental | Behavioral: Vinyasa yoga groupThe vinyasa yoga practice will be 60 minutes in duration and includes standing, seated, and supine postures in the following sequences in order: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series. Participants will be instructed to follow the cues provided in the video and to take any necessary modifications to make each yoga pose more accessible. Vinyasa yoga intervention level 1 will be performed for week 1, level 2 will be performed for week 2, and level 3 will be performed for weeks 3 and 4 of the intervention. |
| Non-active control group | Other | Other: Non-active control groupThe participants in the non-active control condition will serve as a control group. They will be asked to maintain their current lifestyle habits and refrain from starting a new exercise and/or yoga program. A staff member will contact each participant weekly to check in and review any changes to their medical history or activity levels. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Insomnia Severity Index (ISI) score ≥ 10
- Age 18-55 years
- Insufficiently active defined by the Stanford Leisure-Time Activity Categorical Item responses below public health physical activity guidelines
Key exclusion criteria (8 listed)
- Self-reported regular vinyasa and/or power yoga practice defined as ≥ 60 minutes/week within the past 3 months
- Diagnosed medical condition requiring medical clearance defined as a 'yes' response on follow-up questions pertaining to a present medical condition(s) via Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Physical limitations and/or mobility restriction that would interfere with the ability to perform yoga defined as a 'yes' response on the PAR-Q+; self-reported lack of treatment for a major psychiatric disorder via medical history survey
- High risk for obstructive sleep apnea defined as score ≥ 5 via STOP-Bang score
- Self-reported current pregnancy or planning to become pregnant within the next 3 months
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 |
|---|---|---|
| Vinyasa yoga groupParticipants will be instructed to perform a pre-recorded 60-minute vinyasa yoga session 3 times a week for 4 weeks. | Behavioural | Vinyasa yoga group |
| Non-active control groupParticipants will be instructed to sit quietly for 60 minutes and watch a nature documentary during this time. The participants will be asked to maintain their current lifestyle habits and refrain from starting a new exercise and/or yoga program. | Other | Non-active control group |
Primary outcome
Change in Insomnia Severity Index
Time frame: Baseline, post-intervention (4 weeks)
Insomnia Severity Index is a 7-item self-report questionnaire that assesses the severity of the nighttime and daytime impact of insomnia symptoms. Each question is rated on a 5-point Likert scale, with a score of 0 indicating 'no problem' and 4 indicating 'very severe'. The total score is obtained by summing the scores of the individual items ranging from 0 to 28; a higher score indicates more severe insomnia symptoms.
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD)
Time frame: Baseline, post-intervention (4 weeks)
Nocturnal root mean square of successive difference between normal heartbeats will be assessed for 1 night with a Polar heart rate monitor strap; an increase indicates better cardiovascular health
10 secondary outcomes
Change from baseline sleep efficiency at 4 weeks
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline total sleep time at 4 weeks
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline resting systolic blood pressure at 4 weeks
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline resting heart rate at 4 weeks
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline resting carotid-femoral pulse wave velocity
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline quality of sleep
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline in Epworth Sleepiness Scale
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline in Ford Insomnia Response to Stress Test
Time frame: Baseline, post-intervention (4 weeks)
Change from baseline in Patient Health Questionnaire
Time frame: Baseline, post-intervention ( 4 weeks)
Change from baseline in Generalized Anxiety Disorder-7 Questionnaire
Time frame: Baseline, post-intervention (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual deidentified data that are relevant to the primary aims of the study will be provided by external researchers along with a relevant data dictionary.
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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.
Caitlin A. Cheruka, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vinyasa yoga group in people with Insomnia and Insomnia, Psychophysiological, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: Baseline, post-intervention (4 weeks)). The study lists 2 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 7 Jul 2023.