Effects of Hypoxic Breathwork (NCT06317259) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Hypoxic Breathwork
United States75 participantsStarted 2024-06-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Current or past regular breathwork practice
. Current use of psychoactive medications (e.g., anti-depressants or anxiolytics)
. Pregnancy
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves hypoxic breathwork, which deliberately reduces oxygen levels during breathing exercises — given my current health, are there any heart, lung, or blood pressure conditions that would make participating in hypoxic breathwork risky for me?
2The study is measuring brainwave activity (EEG) and sleep patterns before and after the intervention — what does that kind of data collection actually involve, and is there anything about my sleep health I should consider before enrolling?
3Since this trial has three separate groups — one doing hypoxic breathwork with music and affirmations, one doing breathwork only, and one doing just music and affirmations — is there any way to know which group I'd be assigned to, and does it matter for my situation?
4This is listed as a Phase NA study, which often means it's more exploratory research than a treatment trial — should I think of this as a wellness or research participation experience rather than something aimed at treating a specific condition?
5Are there any standard approaches to improving sleep or stress that I should consider first, before committing to a study that involves deliberate breathwork-induced hypoxia?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EEG power and/or connectivity differences between groups
Timeframe: Day 7 and Day 14 or 21 (beginning and end of daily practice week)
2
Group differences in sleep EEG power and/or stage changes from baseline to the intervention period
Timeframe: Days 7-14 or 21 (intervention) vs Days 1-7 (baseline)