The Yoga and Insomnia Study (YOGi)

University of Pittsburgh

Status: Completed

Conditions: Sleep Disorder; Insomnia, Psychophysiological; Insomnia

Treatments: Behavioral: Vinyasa yoga group; Other: Non-active control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05723211

STUDY22110168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Vinyasa yoga group

Experimental group

Description:

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.

Treatment:

Behavioral: Vinyasa yoga group

Non-active control group

Other group

Description:

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.

Treatment:

Other: Non-active control group