SleepNCT05756686
Influence of Yogic Breathwork on Sleep
A study testing Breathing Group 1 and Breathing Group 2 in people with Sleep, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Breathing Group 1 and Breathing Group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- able to provide their consent to be in the study
- available and able to participate in study activities
- who can lie in supine
- who have little to no prior/current regular practice of breath awareness and training
- compatible devices for physiological data trackers
Who cannot join
- Inability to provide informed consent
- history of neurological disorders, craniospinal disorders, spinal injury
- diagnosed/treated sleep disorders such as sleep apnea with the use of CPAP
- allergic or respiratory disorders
- major or uncontrolled psychiatric illness or trauma or major depression
- lung and heart problems
Show all 9Show fewer
- any condition requiring the use of medication that acts on the brain like stimulants/sedatives
- current substance abuse issues
- pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Quantifying the Influence of Yogic Breathwork on Sleep
The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.
Read the detailed description
The purpose of this study is to determine the effects of two remotely-delivered 8-week breathing interventions on long term sleep patterns.
The study protocol consists of healthy participants (randomized in two breathing groups) undergoing a remotely delivered 8-week intervention and a 12-week sleep tracking period (including 2 week before the intervention, 8 week during the intervention, and 2 week after the intervention). Several sleep metrics will be extracted to characterize long-term sleep patterns and degree of sleep improvement. Participants will also be asked to complete pre- and post-intervention questionnaires.
The two remotely delivered interventions will be guided by two separate certified experienced yoga teachers. Both interventions will include 60-minute weekly group virtual sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week) using home-aid practice materials.
- Conditions
- Sleep
- Being tested
- Breathing Group 1, Breathing Group 2
- Keywords
- Sleep, Yogic Breathwork, Digital Health Technology, Yoga, Yogic Breathing, Slow Breathing, Sleep Tracking, Remote Research Studies, Wearable Devices
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Group 1Behavioural
The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
Breathing Group 2Behavioural
The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Group 1 | Experimental | 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). Receives: Behavioral: Breathing Group 1 |
| Breathing Group 2 | Active comparator | 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). Receives: Behavioral: Breathing Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency (SE)
SE is a measure ranging from 0 to 100% indicating the percentage time spent asleep relative to total time in bed. SE will be extracted during a 12-week period to then compute changes in SE.
Measured: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Wake after sleep onset (WASO)
WASO is the percentage of time spent awake during the remainder of the sleep period, after the first sleep onset. WASO will be extracted during a 12-week period to then compute changes in WASO.
Measured: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Secondary outcomes (5)
Total sleep time (TST)
TST is the total time spent asleep. TST will be extracted during a 12-week period to then compute changes in TST.
Measured: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Sleep latency (SL)
SL is defined by the number of minutes spent awake in bed, prior to first sleep onset. SL will be extracted during a 12-week period to then compute changes in SL.
Measured: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-reported questionnaire that is used to assess sleep quality. PSQI scores range from 0 to 21, with higher scores indicating worse outcome.
Measured: During 2 weeks pre-intervention and 2 weeks post-intervention period
36-Item Short Form Survey Instrument (SF-36)
SF-36 is a self-reported questionnaire that is used to assess overall health. SF-36 scores range from 0 to 100, with higher scores indicating better health status.
Measured: During 2 weeks pre-intervention and 2 weeks post-intervention period
Perceived Stress Scale (PSS)
PSS is a self-reported questionnaire that is used to measure the perception of stress. PSS scores range from 10 to 40, with higher scores indicating worse outcome.
Measured: During 2 weeks pre-intervention and 2 weeks post-intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start20 Sep 2023
- Primary completion7 Feb 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Selda Yildiz, Oregon Health and Science University
- Investigators
- Selda Yildiz, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756686
- Sponsor's protocol ID
- STUDY00025528
- Other IDs
- R00AT010158
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Influence of Yogic Breathwork on Sleep
- ClinicalTrials.gov ID
- NCT05756686
- Acronym / sponsor ID
- STUDY00025528
- Conditions
- Sleep
- Keywords
- Sleep, Yogic Breathwork, Digital Health Technology, Yoga, Yogic Breathing, Slow Breathing, Sleep Tracking, Remote Research Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.
Detailed description
The purpose of this study is to determine the effects of two remotely-delivered 8-week breathing interventions on long term sleep patterns.
The study protocol consists of healthy participants (randomized in two breathing groups) undergoing a remotely delivered 8-week intervention and a 12-week sleep tracking period (including 2 week before the intervention, 8 week during the intervention, and 2 week after the intervention). Several sleep metrics will be extracted to characterize long-term sleep patterns and degree of sleep improvement. Participants will also be asked to complete pre- and post-intervention questionnaires.
The two remotely delivered interventions will be guided by two separate certified experienced yoga teachers. Both interventions will include 60-minute weekly group virtual sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week) using home-aid practice materials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Group 1 | Experimental | Behavioral: Breathing Group 1Arm 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). |
| Breathing Group 2 | Active comparator | Behavioral: Breathing Group 2Arm 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age
- able to provide their consent to be in the study
- available and able to participate in study activities
- who can lie in supine
- who have little to no prior/current regular practice of breath awareness and training
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- history of neurological disorders, craniospinal disorders, spinal injury
- diagnosed/treated sleep disorders such as sleep apnea with the use of CPAP
- allergic or respiratory disorders
- major or uncontrolled psychiatric illness or trauma or major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Group 1The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher. | Behavioural | Breathing Group 1 |
| Breathing Group 2The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher. | Behavioural | Breathing Group 2 |
Primary outcome
Sleep efficiency (SE)
Time frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
SE is a measure ranging from 0 to 100% indicating the percentage time spent asleep relative to total time in bed. SE will be extracted during a 12-week period to then compute changes in SE.
Wake after sleep onset (WASO)
Time frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
WASO is the percentage of time spent awake during the remainder of the sleep period, after the first sleep onset. WASO will be extracted during a 12-week period to then compute changes in WASO.
5 secondary outcomes
Total sleep time (TST)
Time frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Sleep latency (SL)
Time frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Pittsburgh Sleep Quality Index (PSQI)
Time frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
36-Item Short Form Survey Instrument (SF-36)
Time frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
Perceived Stress Scale (PSS)
Time frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Study Pre-Screener SurveyLink provided by the sponsor.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Yildiz, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Group 1 and Breathing Group 2 in people with Sleep, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (SE) (time frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.