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NCT Number: NCT05723211

The Yoga and Insomnia Study

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.

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Key information

Conditions

Insomnia Behavior Dyssomnias Insomnia, Psychophysiological Mental Disorders Motor Activity Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Vinyasa yoga group

Behavioral

Participants will be instructed to perform a pre-recorded 60-minute vinyasa yoga session 3 times a week for 4 weeks.

Non-active control group

Other

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Change from baseline sleep efficiency at 4 weeks

    Time frame: Baseline, post-intervention (4 weeks)

    Actigraphy-assessed sleep efficiency, averaged over 7 nights

  2. Change from baseline total sleep time at 4 weeks

    Time frame: Baseline, post-intervention (4 weeks)

    Actigraphy-assessed total sleep time, averaged over 7 nights

  3. Change from baseline resting systolic blood pressure at 4 weeks

    Time frame: Baseline, post-intervention (4 weeks)

    Resting systolic blood pressure will be measured using an automated blood pressure system in the seated position

  4. Change from baseline resting heart rate at 4 weeks

    Time frame: Baseline, post-intervention (4 weeks)

    Resting heart rate will be measured using a automated blood pressure system in the seated position

  5. Change from baseline resting carotid-femoral pulse wave velocity

    Time frame: Baseline, post-intervention (4 weeks)

    Pulse wave velocity is a measure of arterial stiffness

  6. Change from baseline quality of sleep

    Time frame: Baseline, post-intervention (4 weeks)

    Sleep quality will be assessed using a sleep diary on a scale of 'very poor' to 'very good'

  7. Change from baseline in Epworth Sleepiness Scale

    Time frame: Baseline, post-intervention (4 weeks)

    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.

  8. Change from baseline in Ford Insomnia Response to Stress Test

    Time frame: Baseline, post-intervention (4 weeks)

    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.

  9. Change from baseline in Patient Health Questionnaire

    Time frame: Baseline, post-intervention ( 4 weeks)

    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.

  10. Change from baseline in Generalized Anxiety Disorder-7 Questionnaire

    Time frame: Baseline, post-intervention (4 weeks)

    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.

Other outcomes

  1. Sleep efficiency

    Time frame: Immediately after first intervention session (1 night)

    Mean actigraphy-assessed sleep efficiency will be immediately assessed after the initial session of the intervention for 1 night

  2. Total sleep time

    Time frame: Immediately after first intervention session (1 night)

    Mean actigraphy-assessed total sleep time will be immediately assessed after the initial session of the intervention

  3. Nocturnal root mean square of successive difference between normal heartbeats

    Time frame: Immediately after first intervention session (1 night)

    Nocturnal root mean square of successive difference between normal heartbeats will be assessed immediately after the first intervention session for 1 night; an increase value indicates better cardiovascular health

  4. Change in acute anxiety symptoms

    Time frame: pre- and post-initial intervention session

    Acute anxiety symptoms will be measured using the State-Trait Inventory 20-item pre- and post-initial first intervention session

  5. Change in mood

    Time frame: pre- and post-initial intervention session

    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

  6. Change in percent body composition

    Time frame: baseline, post-intervention (4 weeks)

    Body composition will be measured using the bio-electrical impedance; a decrease in percentage indicates improved body composition

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

The Effects of a 4-week Vinyasa Yoga Program on Sleep and Cardiovascular Health in Adults With Insomnia Symptoms: A Randomized Controlled Trial

Acronym: YOGi

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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