HypoventilationNCT05846425
Investigating the Effect of Yoga-based Breathing Styles on the Human Brain, With a Focus on Memory
A study testing Nose-breathing training and Mouth-breathing training in people with Hypoventilation and Hyperventilation, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoventilation, Hyperventilation
- What is being tested?
- Nose-breathing training and Mouth-breathing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2023to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to take on the 2-week exercises but no new athletic or meditative activities
- Yoga-naive and without significant prior experience in various meditative or athletic disciplines that ostensibly involve elements of breath control
- Access to a device with internet access
- Signing of the consent form to participate in the study
Who cannot join
- Known clinically relevant internal or neurological diseases, especially if associated with chronic pathological oxygenation (e.g. COPD, severe bronchial asthma, sleep apnea, but also CKD).
- History of drug or alcohol abuse
- Known psychiatric illnesses that currently require therapy (e.g., pronounced claustrophobia)
- Medication that could falsify the data collected
- Lack of consent to take note of possible incidental findings
- known epileptic seizures, which could be intensified by the visual insertion of the stimuli
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Diagnostic and Interventional Neuroradiology, Saarland University Medical Center
Homburg, Saarland, 66421
Christoph M Krick, Dr.rer.med., +49 6841 16 24359, christoph.krick@uks.eu
Maximilian A Becker, +49 176 20205231, maximilian_arno.becker@uni-saarland.de
About this study
The goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises.
The main questions it aims to answer are:
Read more
- Can the memory performance get better ?
- Can the subjective stress level be reduced ?
Participants will complete a memory test while doing a specific nasal and oral breathing.
They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group, the are divided into.
Researchers will compare the effect of different breathing styles on memory ability among themselves.
Read the detailed description
The goal of this clinical trial is to learn about the effect of yoga-based breathing styles on the human brain regarding memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the performance of the breathing exercises.
The main questions it aims to answer are:
- Is there an improve of memory performance through performing the controlled yoga-based breathing styles ?
- Is there a relevant reduction of the subjective stress level through performing the controlled yoga-based breathing styles
Participants will complete a memory test while performing controlled nasal and oral breathing.
They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group assignment.
Researchers will compare the nasal breathing group to the mouth breathing and the comparison group to see if the nasal breathing results in a significant improvement of the memory capacity.
- Conditions
- Hypoventilation, Hyperventilation
- Being tested
- Nose-breathing training, Mouth-breathing training
- Keywords
- Mnemonic similarity task, Yoga-breathing, Memory enhancement
- Medical subject headings
- Hypoventilation, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nose-breathing trainingOther
13 days of controlled nose-breathing training at a specific frequency with a duration of approximately 15 min a day
Mouth-breathing trainingOther
13 days of controlled mouth-breathing training at a specific frequency with a duration of approximately 15 min a day
| Study group | Role | What they receive |
|---|---|---|
| Nose-breathing | Experimental | Controlled nose-breathing Receives: Other: Nose-breathing training |
| Mouth-breathing | Active comparator | Controlled mouth-breathing Receives: Other: Mouth-breathing training |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of learned images
Memory improvement by performing the home nasal breathing training. The correctness of the mapping is measured by the percentage correctness of the given answers in the memory test, which takes place promptly after the learning phase and 2 weeks later.
Measured: 2 weeks
Secondary outcomes (1)
Reduction of subjective stress level
The subjective stress level is determined by a subjective stress statement, before and after each learning and retrieval phase, at the first appointment and at the second after 2 weeks.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Jun 2023
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- 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
- Model description
- Nose-breathing group, Mouth-breathing group, Control group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Krick, Dr.rer.med., Principal investigator, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846425
- Sponsor's protocol ID
- MST-Breathing Study
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zelano C, Jiang H, Zhou G, Arora N, Schuele S, Rosenow J, Gottfried JA. Nasal Respiration Entrains Human Limbic Oscillations and Modulates Cognitive Function. J Neurosci. 2016 Dec 7;36(49):12448-12467. doi: 10.1523/JNEUROSCI.2586-16.2016.
PubMed 27927961Klippenstein JL, Stark SM, Stark CEL, Bennett IJ. Neural substrates of mnemonic discrimination: A whole-brain fMRI investigation. Brain Behav. 2020 Mar;10(3):e01560. doi: 10.1002/brb3.1560. Epub 2020 Feb 3.
PubMed 32017430Stark SM, Kirwan CB, Stark CEL. Mnemonic Similarity Task: A Tool for Assessing Hippocampal Integrity. Trends Cogn Sci. 2019 Nov;23(11):938-951. doi: 10.1016/j.tics.2019.08.003. Epub 2019 Oct 6.
PubMed 31597601
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Yoga-based Breathing Styles on the Human Brain, With a Focus on Memory
- ClinicalTrials.gov ID
- NCT05846425
- Acronym / sponsor ID
- MST-Breathing Study
- Conditions
- Hypoventilation, Hyperventilation
- Keywords
- Mnemonic similarity task, Yoga-breathing, Memory enhancement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 May 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 goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises.
The main questions it aims to answer are:
- Can the memory performance get better ?
- Can the subjective stress level be reduced ?
Participants will complete a memory test while doing a specific nasal and oral breathing.
They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group, the are divided into.
Researchers will compare the effect of different breathing styles on memory ability among themselves.
Detailed description
The goal of this clinical trial is to learn about the effect of yoga-based breathing styles on the human brain regarding memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the performance of the breathing exercises.
The main questions it aims to answer are:
- Is there an improve of memory performance through performing the controlled yoga-based breathing styles ?
- Is there a relevant reduction of the subjective stress level through performing the controlled yoga-based breathing styles
Participants will complete a memory test while performing controlled nasal and oral breathing.
They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group assignment.
Researchers will compare the nasal breathing group to the mouth breathing and the comparison group to see if the nasal breathing results in a significant improvement of the memory capacity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Nose-breathing group, Mouth-breathing group, Control group
| Arm | Type | Receives |
|---|---|---|
| Nose-breathing | Experimental | Other: Nose-breathing trainingControlled nose-breathing |
| Mouth-breathing | Active comparator | Other: Mouth-breathing trainingControlled mouth-breathing |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to take on the 2-week exercises but no new athletic or meditative activities
- Yoga-naive and without significant prior experience in various meditative or athletic disciplines that ostensibly involve elements of breath control
- Access to a device with internet access
- Signing of the consent form to participate in the study
Key exclusion criteria (6 listed)
- Known clinically relevant internal or neurological diseases, especially if associated with chronic pathological oxygenation (e.g. COPD, severe bronchial asthma, sleep apnea, but also CKD).
- History of drug or alcohol abuse
- Known psychiatric illnesses that currently require therapy (e.g., pronounced claustrophobia)
- Medication that could falsify the data collected
- Lack of consent to take note of possible incidental findings
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 |
|---|---|---|
| Nose-breathing training13 days of controlled nose-breathing training at a specific frequency with a duration of approximately 15 min a day | Other | Nose-breathing |
| Mouth-breathing training13 days of controlled mouth-breathing training at a specific frequency with a duration of approximately 15 min a day | Other | Mouth-breathing |
Primary outcome
Improvement of learned images
Time frame: 2 weeks
Memory improvement by performing the home nasal breathing training. The correctness of the mapping is measured by the percentage correctness of the given answers in the memory test, which takes place promptly after the learning phase and 2 weeks later.
1 secondary outcome
Reduction of subjective stress level
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 27927961Zelano C, Jiang H, Zhou G, Arora N, Schuele S, Rosenow J, Gottfried JA. Nasal Respiration Entrains Human Limbic Oscillations and Modulates Cognitive Function. J Neurosci. 2016 Dec 7;36(49):12448-12467. doi: 10.1523/JNEUROSCI.2586-16.2016.
- Background: PubMed 32017430Klippenstein JL, Stark SM, Stark CEL, Bennett IJ. Neural substrates of mnemonic discrimination: A whole-brain fMRI investigation. Brain Behav. 2020 Mar;10(3):e01560. doi: 10.1002/brb3.1560. Epub 2020 Feb 3.
- Background: PubMed 31597601Stark SM, Kirwan CB, Stark CEL. Mnemonic Similarity Task: A Tool for Assessing Hippocampal Integrity. Trends Cogn Sci. 2019 Nov;23(11):938-951. doi: 10.1016/j.tics.2019.08.003. Epub 2019 Oct 6.
- Individual participant dataSharing planned: No
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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.
Christoph Krick, Dr.rer.med. principal investigator
University of Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nose-breathing training and Mouth-breathing training in people with Hypoventilation and Hyperventilation, run by Universität des Saarlandes at 1 site in Germany.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maximilian A Becker (+49 176 20205231, maximilian_arno.becker@uni-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of learned images (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846425, which also lists 3 linked publications.
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 17 Apr 2024.