What side effects are associated with this type of intervention?

Common treatments for sleep that focus on relaxation, meditation, and guided imagery, such as yogic breathing practices, generally have minimal side effects. These non-pharmacological approaches are designed to reduce stress and improve autonomic nervous system regulation, leading to better sleep quality. Potential side effects may include temporary discomfort or emotional release during practice, but these are typically mild and transient. Overall, these methods are considered safe and well-tolerated.

What prior FDA approvals exist?

FDA-approved treatments for sleep disorders primarily include pharmacological options such as benzodiazepines, non-benzodiazepine sleep aids like zolpidem and eszopiclone, and melatonin receptor agonists like ramelteon. Non-pharmacological treatments, though not FDA-approved in the same regulatory sense, include cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based stress reduction (MBSR), which focus on stress reduction and autonomic nervous system regulation to improve sleep quality.

What other types of research exist?

Promising alternatives to yogic breathing practices for regulating the autonomic nervous system and reducing stress in sleep patients include mindfulness-based stress reduction (MBSR), acupuncture, and guided imagery. These interventions have demonstrated efficacy in improving sleep quality, reducing stress, and enhancing overall well-being.

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Yogic Breathing for Sleep Improvement

N/A

Waitlist Available

Led By Selda Yildiz, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of a yogic breathing practice on sleep quality, stress reduction, and overall quality of life in healthy individuals. Participants will join regular online group sessions and do home exercises. The breathing exercises are expected to help participants relax and manage stress, which may improve their sleep.

Who is the study for?

This trial is for adults aged 18-65 who can lie down comfortably, have compatible devices for tracking physiological data, and are new to breathwork practices. It's not suitable for those on brain-affecting meds, with major psychiatric conditions or substance abuse issues, respiratory or heart problems, pregnant/nursing women, or diagnosed sleep disorders.

What is being tested?

The study aims to see if 8 weeks of yogic breathing exercises can improve sleep quality and overall life satisfaction while reducing stress. Participants will be randomly assigned to one of two different breathing practice groups.

What are the potential side effects?

Since the intervention involves non-invasive breathing techniques, significant side effects are not anticipated. However, participants may experience mild discomfort like dizziness or shortness of breath during the practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep efficiency (SE)

Wake after sleep onset (WASO)

Secondary study objectives

36-Item Short Form Survey Instrument (SF-36)

Perceived Stress Scale (PSS)

Pittsburgh Sleep Quality Index (PSQI)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Breathing Group 1Experimental Treatment1 Intervention

Arm 1 will receive an 8-week remotely delivered intervention that consists of a set of breathing practices through 60-minute weekly virtual group sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week).

Group II: Breathing Group 2Active Control1 Intervention

Arm 2 will receive an 8-week remotely delivered intervention that consists of slow breathing practices through 60-minute weekly virtual group sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sleep, such as yogic breathing practices, work by regulating the autonomic nervous system and reducing stress. These practices involve controlled breathing, mindfulness, and relaxation techniques that decrease sympathetic nervous system activity (responsible for the 'fight or flight' response) and enhance parasympathetic activity (promoting 'rest and digest' functions). This shift helps lower heart rate and blood pressure, reduce anxiety, and promote a state of calm conducive to sleep. For sleep patients, these mechanisms are crucial as they directly address stress and autonomic imbalances, which are often at the root of sleep disturbances.

Non-pharmacological interventions for sleep promotion in hospitalized children.