The Yoga and Insomnia Study (YOGi)

July 6, 2023 updated by: Caitlin Cheruka, University of Pittsburgh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vinyasa yoga group
The vinyasa yoga practice will be 60 minutes in duration and includes standing, seated, and supine postures in the following sequences in order: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series. Participants will be instructed to follow the cues provided in the video and to take any necessary modifications to make each yoga pose more accessible. Vinyasa yoga intervention level 1 will be performed for week 1, level 2 will be performed for week 2, and level 3 will be performed for weeks 3 and 4 of the 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
The participants in the non-active control condition will serve as a control group. They will be asked to maintain their current lifestyle habits and refrain from starting a new exercise and/or yoga program. A staff member will contact each participant weekly to check in and review any changes to their medical history or activity levels.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-intervention (4 weeks)
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
Baseline, post-intervention (4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline sleep efficiency at 4 weeks
Time Frame: Baseline, post-intervention (4 weeks)
Actigraphy-assessed sleep efficiency, averaged over 7 nights
Baseline, post-intervention (4 weeks)
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
Baseline, post-intervention (4 weeks)
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
Baseline, post-intervention (4 weeks)
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
Baseline, post-intervention (4 weeks)
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
Baseline, post-intervention (4 weeks)
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'
Baseline, post-intervention (4 weeks)
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.
Baseline, post-intervention (4 weeks)
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.
Baseline, post-intervention (4 weeks)
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.
Baseline, post-intervention ( 4 weeks)
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.
Baseline, post-intervention (4 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Immediately after first intervention session (1 night)
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
Immediately after first intervention session (1 night)
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
Immediately after first intervention session (1 night)
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
pre- and post-initial intervention session
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
pre- and post-initial intervention session
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
baseline, post-intervention (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caitlin A. Cheruka, MS, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY22110168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual deidentified data that are relevant to the primary aims of the study will be provided by external researchers along with a relevant data dictionary.

IPD Sharing Time Frame

Beginning 1 year following peer-reviewed publication of research questions outlined in the specific aims and ending 5 years following publication of study results

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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