The Yoga and Insomnia Study

NCT05723211 | Completed

• 1 other identifier: STUDY22110168
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Insomnia, Psychophysiological; Sleep Disorder

Keywords

sleep; cardiovascular; insomnia; yoga; physical activity

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• Change from baseline sleep efficiency at 4 weeks

  Baseline, post-intervention (4 weeks)

• Change from baseline total sleep time at 4 weeks

  Baseline, post-intervention (4 weeks)

• Change from baseline resting systolic blood pressure at 4 weeks

  Baseline, post-intervention (4 weeks)

• Change from baseline resting heart rate at 4 weeks

  Baseline, post-intervention (4 weeks)

• Change from baseline resting carotid-femoral pulse wave velocity

  Baseline, post-intervention (4 weeks)

Other Outcomes (6)

• Sleep efficiency

  Immediately after first intervention session (1 night)

• Total sleep time

  Immediately after first intervention session (1 night)

• Nocturnal root mean square of successive difference between normal heartbeats

  Immediately after first intervention session (1 night)

Study Arms (2)

Vinyasa yoga group

EXPERIMENTAL

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

Non-active control group

OTHER

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

Interventions

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.

Vinyasa yoga group

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.

Non-active control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Caitlin A. Cheruka, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting the outcome assessments will be blinded to the participant intervention group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student Researcher

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: March 1, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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.

Locations

US (1)