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Non-active control group for Insomnia (YOGi Trial)

N/A

Waitlist Available

Led By Caitlin A. Cheruka, MS

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (4 weeks)

Awards & highlights

YOGi Trial Summary

This trial will investigate whether yoga can improve sleep and cardiovascular health in adults with insomnia.

Eligible Conditions

Insomnia
Sleep Disorders

YOGi Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Insomnia Severity Index

Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD)

Secondary outcome measures

Change from baseline in Epworth Sleepiness Scale

Change from baseline in Ford Insomnia Response to Stress Test

Change from baseline in Generalized Anxiety Disorder-7 Questionnaire

+7 more

Other outcome measures

Change in acute anxiety symptoms

Change in mood

Change in percent body composition

+3 more

YOGi Trial Design

2Treatment groups

Experimental Treatment

Group I: Vinyasa yoga groupExperimental Treatment1 Intervention

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 II: Non-active control groupExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinyasa yoga group

2023

N/A

~40

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Who is running the clinical trial?

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,342,308 Total Patients Enrolled

8 Trials studying Insomnia

1,082 Patients Enrolled for Insomnia

Caitlin A. Cheruka, MSPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accessible to individuals aged fifty and above?

"The minimum age of eligibility for this trial is 18 years old, while the maximum accepted age is 55."

Answered by AI

Is it practicable for me to participate in this experiment?

"Qualified candidates for this medical trial should be aged between 18 and 55 years old, have a primary diagnosis of insomnia, and there must still be 32 spots available."

Answered by AI

Is this evaluation currently accessible to participant recruitment?

"The information found on clinicaltrials.gov confirms that the medical study is no longer enrolling patients, with its first post date of February 1st 2023 and last edit taking place on the same day. Nonetheless, 296 other trials are actively looking for volunteers at this time."

Answered by AI

What is the main goal of this research endeavor?

"This clinical trial is primarily looking to assess the alteration of nocturnal RMSSD from baseline over 4 weeks. Secondary goals include monitoring actigraphy-assessed total sleep time, resting systolic blood pressure and heart rate for any changes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Yoga and Insomnia Study

Caitlin Cheruka 2023. "The Yoga and Insomnia Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05723211.