InsomniaNCT07638267
Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga
A study testing Vinyasa yoga and Gentle yoga in people with Insomnia and Health Adult Subjects, run by Caitlin Cheruka at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are: Does the style of yoga impact participants heart health overnight? Does the style of yoga improve participants sleep following a single… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Health Adult Subjects, Insomnia Disorder
- What is being tested?
- Vinyasa yoga and Gentle yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-40 years
- Insufficiently inactive define by the L-CAT (responses below public health physical activity guidelines)
- Physical activity is not contraindicated (i.e., no affirmative responses on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Adults with diagnosed insomnia disorder and score ≥ 10 on the Insomnia Severity Index
- Good sleeps a score < 10 (no history of sleep disorder)
- Basic understanding of yoga poses
- Access to a smart device (such as a smartphone or tablet)
Who cannot join
- Regular yoga practice (> 60 minutes per week)
- Any diagnosed medical condition requiring medical clearance determined 'Yes' response on questions pertaining to a present medical condition(s) via PAR-Q+. This includes, but is not limited to, uncontrolled cardiovascular, metabolic, respiratory, musculoskeletal, neurological, or mental health conditions; recent stroke or concussion; active cancer treatment; and any combination of medical conditions that pose a health risk without physician supervision. All "yes" responses on the PAR-Q+ will be evaluated, and individuals requiring clearance will not be eligible to participate.
- Physical limitations and/or mobility restrictions (such as bone, joint, or soft tissue such as muscle, ligament, or tendon that could be made worse by becoming more physically active) via PAR-Q+
- Untreated major psychiatric disorders (e.g. major depression, bipolar disorder, schizophrenia)
- Elevated risk for sleep apnea (i.e., STOP-Bang score ≥ 5)
- Any other sleep disorders other than insomnia (e.g., sleep apnea, restless legs syndrome, circadian rhythm disorder, etc.)
Show all 10Show fewer
- Current treatment for insomnia (e.g., hypnotic medications, cognitive behavioral therapy for insomnia, etc.)
- Current medications that affect heart or blood pressure (i.e., anti-depressants, beta-blockers, etc.)
- Current or planned pregnancy within the next 3 months
- Overnight shift work defined as regularly working anytime between 00:00 and 6:00am
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Caitlin A. Cheruka, PhD, 610-247-5030, caitlin.cheruka@ucf.edu
About this study
Official title: Effects of a Single Evening Session of Vinyasa Yoga to Gentle Yoga on Sleep and Cardiovascular Health in Adults
The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are:
- Does the style of yoga impact participants heart health overnight?
- Does the style of yoga improve participants sleep following a single session? Researchers will compare adults with insomnia disorder to adults with healthy sleep .
Read more
Participants will:
- Complete a moderate-intensity yoga practice, a low-intensity intensity yoga practice, and a quiet rest period while watching a nature documentary in the evening on three separate evenings
- Participants will have their sleep and heart health measured using a watch and heart rate monitor overnight following each visit
Read the detailed description
This study investigates how two different styles of yoga, vinyasa yoga and gentle yoga, impact sleep and heart health in adults with and without insomnia. Insomnia, a common sleep disorder, increases the risk of heart disease, the leading cause of death worldwide. Recently, the American Heart Association identified poor sleep as a key factor in maintaining heart health, yet there is limited research on therapies that can simultaneously improve both sleep and cardiovascular function. By examining the immediate effects of a single evening session of yoga, this study aims to determine if yoga could serve as a practical, complementary approach to managing sleep and heart health.
Using a three-arm randomized crossover design, the study includes 42 participants, aged 18-40, who are either good sleepers or have diagnosed insomnia. Each participant will complete three sessions: one of vinyasa yoga, one of gentle yoga, and a non-active control session, with each session separated by a 72-hour washout period to avoid carryover effects. The yoga sessions will be standardized to 60 minutes and take place in the evening, approximately 4-6 hours before bedtime, under the supervision of a trained research staff.
The study has three main goals. First, examine whether different yoga styles influence heart function during sleep by measuring heart rate variability (HRV), a marker of nervous system balance that reflects the body's ability to regulate stress and relaxation. The investigators hypothesize that both yoga styles will improve HRV in people with insomnia more than in healthy sleepers. Second, to determine if vinyasa or gentle yoga improves sleep quality-measured by sleep efficiency (the percentage of time in bed spent asleep), total sleep time, and self-reported sleep quality-in adults with insomnia compared to those without sleep problems. Lastly, measure the impact of yoga on blood vessel function using flow-mediated dilation (FMD), a test that measures how well blood vessels expand in response to increased blood flow, with the expectation that vinyasa yoga's moderate intensity will provide greater immediate benefits compared to gentle yoga.
- Being tested
- Vinyasa yoga, Gentle yoga, Non-active control
- Keywords
- sleep, insomnia, yoga, heart health, heart rate variability, actigraphy
- 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.
Vinyasa yogaBehavioural
Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the vinyasa yoga session. The 60-minute vinyasa yoga protocol incorporated standing, seated, and supine postures and included the following order of sequences: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series.
Gentle yogaBehavioural
Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the gentle yoga session. This sequence focuses primarily on seated and supine postures and is designed to be accessible, safe, and restorative. All poses are low-impact and supported using yoga blocks to promote comfort and reduce physical strain.
Non-active controlOther
The non-active control session, participants will complete a quiet rest period while watching a nature documentary. The film is educational in nature and has been carefully selected to avoid any graphic, distressing, offensive, or psychologically sensitive content. It is commercially available and rated G for general audiences. Participants will be asked to remain seated and refrain from the use of electronic devices. A staff member will remain present to ensure participants following procedures.
| Study group | Role | What they receive |
|---|---|---|
| vinyasa yoga | Experimental | 60 minute moderate-intensity yoga session Receives: Behavioral: Vinyasa yoga |
| gentle yoga | Experimental | 60 minute low-intensity yoga session Receives: Behavioral: Gentle yoga |
| Control Condition | Other | 60-minute non-active control condition Receives: Other: Non-active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD) heart rate variability (HRV)
Nocturnal root mean square of successive difference between normal heartbeats will be assessed immediately after each experimental session for 1 night; a higher value indicates better cardiovascular health
Measured: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Secondary outcomes (12)
Change in sleep efficiency
Actigraphy-assessed sleep efficiency will be measured overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights. Values are represented as a percentage, with higher values indicating better sleep efficiency
Measured: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in total sleep time
Actigraphy-assessed total sleep time will be immediately assessed after each experimental sessions for 1 night. Total sleep time will be reported in hours.
Measured: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in wake after sleep onset
Actigraphy-assessed wake after sleep onset will be immediately assessed after each experimental sessions for 1 night. Wake after sleep onset will be presented as minutes, the higher the values the more time spent awake during the sleep period.
Measured: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in sleep quality
Diary-assessed sleep quality will be immediately assessed after each experimental sessions the following morning, on 3 seperate mornings. The sleep diary will be the Expanded Consensus Sleep Diary for Evening. Participants will rate their quality of sleep (ranging from 1 ['very poor'] to 5 ['very good'], higher scores indicating better sleep quality.
Measured: The following morning after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate mornings.
Change in nocturnal heart rate
Nocturnal heart rate will be assessed immediately after each experimental session for 1 night (3 seperate nights); a lower resting nocturnal heart rate value indicates better cardiovascular health
Measured: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in systolic blood pressure
Systolic blood pressure will be measured pre- , immediate-post, and 60-minute post following each experimental session
Measured: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in diastolic blood pressure
Diastolic blood pressure will be measured pre- , immediate-post, and 60-minute post following each experimental session
Measured: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in heart rate
heart rate will be measured pre- , immediate-post, and 60-minute post following each experimental session
Measured: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in root mean square of successive difference between normal heartbeats
Root mean square of successive difference between normal heartbeats will be measured pre- , immediate-post, and 60-minute post following each experimental session
Measured: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in flow-mediated dilation
Flow-mediated dilation will be measured pre- , 60-minute post, and delayed-post (morning after) following each experimental session
Measured: pre- , 60-minute post, and delayed-posted (morning after) following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in acute anxiety symptoms
Acute anxiety symptoms will be measured using the State-Trait Inventory 20-item. Each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Scores are summed for a total that ranges from 20-80; higher scores indicate greater symptoms of anxiety.
Measured: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in mood
Acute changes in mood will be measured using the Profile of Mood States brief form. This will assess the feelings of tension, depressed mood, energy, fatigue, and total mood disturbances based on how the participant feels right now using a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely
Measured: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caitlin Cheruka
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor-investigator, Caitlin Cheruka, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638267
- Sponsor's protocol ID
- STUDY00007288
- Other IDs
- 5523
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2026
- Last updated
- 13 Aug 2026
- 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 to external investigators along with a relevant data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Evening Session of Vinyasa Yoga to Gentle Yoga on Sleep and Cardiovascular Health in Adults
- ClinicalTrials.gov ID
- NCT07638267
- Acronym / sponsor ID
- STUDY00007288
- Keywords
- sleep, insomnia, yoga, heart health, heart rate variability, actigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Caitlin CherukaUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jun 2026 (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 goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are:
- Does the style of yoga impact participants heart health overnight?
- Does the style of yoga improve participants sleep following a single session? Researchers will compare adults with insomnia disorder to adults with healthy sleep .
Participants will:
- Complete a moderate-intensity yoga practice, a low-intensity intensity yoga practice, and a quiet rest period while watching a nature documentary in the evening on three separate evenings
- Participants will have their sleep and heart health measured using a watch and heart rate monitor overnight following each visit
Detailed description
This study investigates how two different styles of yoga, vinyasa yoga and gentle yoga, impact sleep and heart health in adults with and without insomnia. Insomnia, a common sleep disorder, increases the risk of heart disease, the leading cause of death worldwide. Recently, the American Heart Association identified poor sleep as a key factor in maintaining heart health, yet there is limited research on therapies that can simultaneously improve both sleep and cardiovascular function. By examining the immediate effects of a single evening session of yoga, this study aims to determine if yoga could serve as a practical, complementary approach to managing sleep and heart health.
Using a three-arm randomized crossover design, the study includes 42 participants, aged 18-40, who are either good sleepers or have diagnosed insomnia. Each participant will complete three sessions: one of vinyasa yoga, one of gentle yoga, and a non-active control session, with each session separated by a 72-hour washout period to avoid carryover effects. The yoga sessions will be standardized to 60 minutes and take place in the evening, approximately 4-6 hours before bedtime, under the supervision of a trained research staff.
The study has three main goals. First, examine whether different yoga styles influence heart function during sleep by measuring heart rate variability (HRV), a marker of nervous system balance that reflects the body's ability to regulate stress and relaxation. The investigators hypothesize that both yoga styles will improve HRV in people with insomnia more than in healthy sleepers. Second, to determine if vinyasa or gentle yoga improves sleep quality-measured by sleep efficiency (the percentage of time in bed spent asleep), total sleep time, and self-reported sleep quality-in adults with insomnia compared to those without sleep problems. Lastly, measure the impact of yoga on blood vessel function using flow-mediated dilation (FMD), a test that measures how well blood vessels expand in response to increased blood flow, with the expectation that vinyasa yoga's moderate intensity will provide greater immediate benefits compared to gentle yoga.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vinyasa yoga | Experimental | Behavioral: Vinyasa yoga60 minute moderate-intensity yoga session |
| gentle yoga | Experimental | Behavioral: Gentle yoga60 minute low-intensity yoga session |
| Control Condition | Other | Other: Non-active control60-minute non-active control condition |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults 18-40 years
- Insufficiently inactive define by the L-CAT (responses below public health physical activity guidelines)
- Physical activity is not contraindicated (i.e., no affirmative responses on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Adults with diagnosed insomnia disorder and score ≥ 10 on the Insomnia Severity Index
- Good sleeps a score < 10 (no history of sleep disorder)
Key exclusion criteria (10 listed)
- Regular yoga practice (> 60 minutes per week)
- Any diagnosed medical condition requiring medical clearance determined 'Yes' response on questions pertaining to a present medical condition(s) via PAR-Q+. This includes, but is not limited to, uncontrolled cardiovascular, metabolic, respiratory, musculoskeletal, neurological, or mental health conditions; recent stroke or concussion; active cancer treatment; and any combination of medical conditions that pose a health risk without physician supervision. All "yes" responses on the PAR-Q+ will be evaluated, and individuals requiring clearance will not be eligible to participate.
- Physical limitations and/or mobility restrictions (such as bone, joint, or soft tissue such as muscle, ligament, or tendon that could be made worse by becoming more physically active) via PAR-Q+
- Untreated major psychiatric disorders (e.g. major depression, bipolar disorder, schizophrenia)
- Elevated risk for sleep apnea (i.e., STOP-Bang score ≥ 5)
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 yogaParticipants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the vinyasa yoga session. The 60-minute vinyasa yoga protocol incorporated standing, seated, and supine postures and included the following order of sequences: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series. | Behavioural | vinyasa yoga |
| Gentle yogaParticipants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the gentle yoga session. This sequence focuses primarily on seated and supine postures and is designed to be accessible, safe, and restorative. All poses are low-impact and supported using yoga blocks to promote comfort and reduce physical strain. | Behavioural | gentle yoga |
| Non-active controlThe non-active control session, participants will complete a quiet rest period while watching a nature documentary. The film is educational in nature and has been carefully selected to avoid any graphic, distressing, offensive, or psychologically sensitive content. It is commercially available and rated G for general audiences. Participants will be asked to remain seated and refrain from the use of electronic devices. A staff member will remain present to ensure participants following procedures. | Other | Control Condition |
Primary outcome
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD) heart rate variability (HRV)
Time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Nocturnal root mean square of successive difference between normal heartbeats will be assessed immediately after each experimental session for 1 night; a higher value indicates better cardiovascular health
12 secondary outcomes
Change in sleep efficiency
Time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in total sleep time
Time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in wake after sleep onset
Time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in sleep quality
Time frame: The following morning after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate mornings.
Change in nocturnal heart rate
Time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Change in systolic blood pressure
Time frame: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in diastolic blood pressure
Time frame: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in heart rate
Time frame: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in root mean square of successive difference between normal heartbeats
Time frame: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in flow-mediated dilation
Time frame: pre- , 60-minute post, and delayed-posted (morning after) following each experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in acute anxiety symptoms
Time frame: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
Change in mood
Time frame: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual deidentified data that are relevant to the primary aims of the study will be provided to external investigators 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.
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 and Gentle yoga in people with Insomnia and Health Adult Subjects, run by Caitlin Cheruka 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin A. Cheruka, PhD (610-247-5030, caitlin.cheruka@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD) heart rate variability (HRV) (time frame: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.). 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 13 Aug 2026.