The Yoga and Insomnia Study

NCT ID: NCT05723211

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-06-26

Brief Summary

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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

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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.

Conditions

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Insomnia Insomnia, Psychophysiological Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The research staff conducting the outcome assessments will be blinded to the participant intervention group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Vinyasa yoga group

Intervention Type 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

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.

Group Type OTHER

Non-active control group

Intervention Type 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.

Interventions

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Vinyasa yoga group

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Caitlin Cheruka

Graduate Student Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caitlin A. Cheruka, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY22110168

Identifier Type: -

Identifier Source: org_study_id

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