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| ID | Type | Description | Link |
|---|---|---|---|
| 5523 | Other Grant/Funding Number | ACSM Foundation |
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| Name | Class |
|---|---|
| American College of Sports Medicine | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vinyasa yoga | Experimental | 60 minute moderate-intensity yoga session |
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| gentle yoga | Experimental | 60 minute low-intensity yoga session |
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| Control Condition | Other | 60-minute non-active control condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinyasa yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Florida | Orlando | Florida | 32816 | United States |
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.
Beginning 1 year following peer-reviewed publication of research questions outlined in grant and ending 5 years following publication of study results
Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Gentle yoga | Behavioral | 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. |
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| Non-active control | Other | 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. |
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| 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control) |
| D001523 |
| Mental Disorders |