Clinical trial NCT05723211: The Yoga and Insomnia 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Insomnia, Psychophysiological
Sleep Disorder
Keywords: sleep
cardiovascular
insomnia
yoga
physical activity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Insomnia Severity Index (ISI) score ≥ 10
2. Age 18-55 years
3. Insufficiently active defined by the Stanford Leisure-Time Activity Categorical Item responses below public health physical activity guidelines

Exclusion Criteria:

1. Self-reported regular vinyasa and/or power yoga practice defined as ≥ 60 minutes/week within the past 3 months
2. 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+)
3. 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
4. High risk for obstructive sleep apnea defined as score ≥ 5 via STOP-Bang score
5. Self-reported current pregnancy or planning to become pregnant within the next 3 months
6. Overnight shift work defined as regularly working any time between 00:00 and 06:00 am
7. Self-reported current treatment for insomnia via medical history survey
8. Medications that may affect heart rate during exercise via self-report on the medical history survey

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD)
timeFrame: Baseline, post-intervention (4 weeks)
Secondary outcomes:
measure: Change from baseline sleep efficiency at 4 weeks
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline total sleep time at 4 weeks
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline resting systolic blood pressure at 4 weeks
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline resting heart rate at 4 weeks
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline resting carotid-femoral pulse wave velocity
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline quality of sleep
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline in Epworth Sleepiness Scale
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline in Ford Insomnia Response to Stress Test
timeFrame: Baseline, post-intervention (4 weeks)
measure: Change from baseline in Patient Health Questionnaire
timeFrame: Baseline, post-intervention ( 4 weeks)
measure: Change from baseline in Generalized Anxiety Disorder-7 Questionnaire
timeFrame: Baseline, post-intervention (4 weeks)
Other outcomes:
measure: Sleep efficiency
timeFrame: Immediately after first intervention session (1 night)
measure: Total sleep time
timeFrame: Immediately after first intervention session (1 night)
measure: Nocturnal root mean square of successive difference between normal heartbeats
timeFrame: Immediately after first intervention session (1 night)
measure: Change in acute anxiety symptoms
timeFrame: pre- and post-initial intervention session
measure: Change in mood
timeFrame: pre- and post-initial intervention session
measure: Change in percent body composition
timeFrame: baseline, post-intervention (4 weeks)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Caitlin A. Cheruka, MS
role: PRINCIPAL_INVESTIGATOR
References: