The Yoga and Insomnia Study

Insomnia Clinical Trial

— YOGi  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723211
• Other study ID #: STUDY22110168
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 26, 2023

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Insomnia, Psychophysiological
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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

Other:
• Non-active control group
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep efficiency	Mean actigraphy-assessed sleep efficiency will be immediately assessed after the initial session of the intervention for 1 night	Immediately after first intervention session (1 night)
Other	Total sleep time	Mean actigraphy-assessed total sleep time will be immediately assessed after the initial session of the intervention	Immediately after first intervention session (1 night)
Other	Nocturnal root mean square of successive difference between normal heartbeats	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	Immediately after first intervention session (1 night)
Other	Change in acute anxiety symptoms	Acute anxiety symptoms will be measured using the State-Trait Inventory 20-item pre- and post-initial first intervention session	pre- and post-initial intervention session
Other	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	pre- and post-initial intervention session
Other	Change in percent body composition	Body composition will be measured using the bio-electrical impedance; a decrease in percentage indicates improved body composition	baseline, post-intervention (4 weeks)
Primary	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.	Baseline, post-intervention (4 weeks)
Primary	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	Baseline, post-intervention (4 weeks)
Secondary	Change from baseline sleep efficiency at 4 weeks	Actigraphy-assessed sleep efficiency, averaged over 7 nights	Baseline, post-intervention (4 weeks)
Secondary	Change from baseline total sleep time at 4 weeks	Actigraphy-assessed total sleep time, averaged over 7 nights	Baseline, post-intervention (4 weeks)
Secondary	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	Baseline, post-intervention (4 weeks)
Secondary	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	Baseline, post-intervention (4 weeks)
Secondary	Change from baseline resting carotid-femoral pulse wave velocity	Pulse wave velocity is a measure of arterial stiffness	Baseline, post-intervention (4 weeks)
Secondary	Change from baseline quality of sleep	Sleep quality will be assessed using a sleep diary on a scale of 'very poor' to 'very good'	Baseline, post-intervention (4 weeks)
Secondary	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.	Baseline, post-intervention (4 weeks)
Secondary	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.	Baseline, post-intervention (4 weeks)
Secondary	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.	Baseline, post-intervention ( 4 weeks)
Secondary	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.	Baseline, post-intervention (4 weeks)