NCT06317259 · University of California, San Diego
Effects of Hypoxic Breathwork
What this study is about
This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork").
View original scientific description
This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality.
Interventions
BEHAVIORAL
Hypoxic breathwork plus music and messaging
Hypoxic breathwork consists of about 5 min of rhythmic breathing in a 4-in/4-out pattern followed by a breath hold on the exhale for about 1-2 min. This is repeated 1-2 times with increasing breath rate up to 2-in/2-out. The audio track also includes dynamic music that accompanies the different stages as well as positive messaging encouraging self-determination.
BEHAVIORAL
Hypoxic breathwork only
Hypoxic breathwork consists of about 5 min of rhythmic breathing in a 4-in/4-out pattern followed by a breath hold on the exhale for about 1-2 min. This is repeated 1-2 times with increasing breath rate up to 2-in/2-out. Other than breathing instructions and pacing, the audio track is silent.
BEHAVIORAL
Music and messaging meditation
Music and messaging meditation consists of dynamic music that is engaging and aids focus, as well as positive messaging encouraging self-determination.
Primary outcome measures
EEG power and/or connectivity differences between groups
Time frame: Day 7 and Day 14 or 21 (beginning and end of daily practice week)
EEG features will be extracted to show the brain responses to rhythmic breathing and hypoxic breath holds that will be compared with music and positive messaging meditation. These groups will also be compared with a breathwork only condition.
Group differences in sleep EEG power and/or stage changes from baseline to the intervention period
Time frame: Days 7-14 or 21 (intervention) vs Days 1-7 (baseline)
Sleep stages and power characteristics will be analyzed during the practice week as compared to the week prior during which they have no intervention. All three experimental groups will be compared.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Persons, aged 18-45
- Availability for the duration of the study
- In good general health as revealed by self-report
- Stated willingness and capability to adhere to the breathwork regimen
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- Provision of signed and dated informed consent form
Exclusion criteria
- Current or past regular breathwork practice
- Current use of psychoactive medications (e.g., anti-depressants or anxiolytics)
- Bedtime past 11:30pm or regularly getting less than 6 hours of sleep per night.
- Feverish illness within 10 days
- Regular smoker or tobacco user ( \> 1 cigarette, gum or pouch per month)
- Presence of blood pressure above 140 systolic and/or 90 diastolic, seizure disorder, asthma, or serious cardiac fibrillation disorders.
Where
- La Jolla, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 6, 2024 · Source of record for eligibility and locations