- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916312
Comparing Effects of Intense Breathwork to Meditation on Altered States of Consciousness (A2A)
June 17, 2025 updated by: Guy Fincham, University of Sussex
Airways to Alteration: Investigating the Impact of Breathwork & Meditation on Conscious State
This study aims to investigate the impact of high ventilation breathwork (HVB) and meditation on altered states of consciousness (ASCs).
The study will compare the effects of a single guided HVB session to a single guided body scan meditation session.
The primary aim is to explore the impact of HVB and meditation on ASCs, while secondary aims relate to mental health and wellbeing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a randomised controlled trial (RCT) involving up to 24 healthy adult participants who have prior experience with HVB.
Participants will be randomly allocated to either the HVB or meditation group.
The study will assess outcomes such as altered states of consciousness, mystical experiences, emotional breakthroughs, and overall wellbeing.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sussex
-
Brighton, Sussex, United Kingdom, BN1 9RH
- University of Sussex
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy adults in Brighton and the surrounding area
- Prior experience practising high ventilation breathwork in the form of conscious connected breathing
- No history of adverse events during such prior breathwork sessions.
Exclusion Criteria:
- History of hypotension
- Hypertension
- Respiratory or cardiovascular problems
- Fainting or syncope
- Epilepsy or seizures
- Panic disorder or panic attacks
- Cerebral aneurysm
- Pregnancy (and possibility one might be pregnant, trying to get pregnant, or are breastfeeding)
- Breathlessness
- Bradypnea
- Tachypnoea
- Any mental/physical issues affecting the ability to engage in breath control activities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Meditation
Single guided body scan meditation session.
|
Single guided body scan meditation session.
Other Names:
|
|
Experimental: High ventilation breathwork
Single guided conscious connected breathing session.
|
Single guided conscious connected breathing session.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Altered states of consciousness
Time Frame: Immediately after the intervention.
|
Five Dimensions of Altered States of Consciousness Scale.
Comprises five subscales: oceanic boundlessness, dread of ego dissolution, visionary restructuralisation, auditory alterations and vigilance reduction.
Scores range from 0 to 100, with higher scores indicating more profound altered states of consciousness.
|
Immediately after the intervention.
|
|
Mystical experience
Time Frame: Immediately after the intervention.
|
Mystical Experience Questionnaire Brief.
Comprises four subscales: transcendence, positive mood, ineffability, and mystical.
Scores range from 0 to 20, with higher scores indicating a more profound mystical experience.
|
Immediately after the intervention.
|
|
Emotional breakthrough
Time Frame: Immediately after the intervention.
|
Emotional Breakthrough Inventory.
Scores range from 0 to 100, with higher scores indicating greater levels of emotional breakthrough (reflecting a better outcome).
|
Immediately after the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological insight
Time Frame: Post-intervention (one week after the intervention).
|
Psychological Insight Scale.
Scores range from 0 to 100, with higher scores indicating greater psychological insight.
An additional item separately evaluates self-reported behavioural change resulting from a psychedelic experience.
|
Post-intervention (one week after the intervention).
|
|
Depersonalisation
Time Frame: Immediately after the intervention.
|
Cambridge Depersonalisation Scale (State-Version).
Scores range from 0 to 100, with higher scores indicating greater levels of dissociative symptoms.
|
Immediately after the intervention.
|
|
Fatigue
Time Frame: Baseline and post-intervention (one week before and after the intervention).
|
Shortened Fatigue Questionnaire.
Scores range from 4 to 28, with higher scores indicating more severe fatigue.
|
Baseline and post-intervention (one week before and after the intervention).
|
|
Sleep-related impairment
Time Frame: Baseline and post-intervention (one week before and after the intervention).
|
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 4a (score range: 5-20; higher scores denote worse outcome).
Data scored using a T-score transformation according to PROMIS Sleep scoring manual on: www.healthmeasures.net
|
Baseline and post-intervention (one week before and after the intervention).
|
|
Mental wellbeing
Time Frame: Baseline and post-intervention (one week before and after the intervention).
|
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (score range: 7 to 35; higher scores denote better outcome).
Total raw scores are then transformed into metric scores using the SWEMWBS conversion table on: www.warwick.ac.uk
|
Baseline and post-intervention (one week before and after the intervention).
|
|
Depressive symptoms, anxiety, and stress
Time Frame: Baseline and post-intervention (one week before and after the intervention).
|
Depression Anxiety Stress Scale-21 (DASS-21) - stress, anxiety and depression subscales (score range for each: 0-21; higher scores denote worse outcomes).
Score on DASS-21 then multiplied by two to convert it to the longer form DASS-42 final score.
|
Baseline and post-intervention (one week before and after the intervention).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychedelic experience predictiveness
Time Frame: After completing consent form to participate in the study.
|
Imperial Psychedelic Predictor Scale.
Scores range from 0 to 100, with higher scores donating higher predictiveness of having a psychedelic experience.
Additional items assess rapport.
|
After completing consent form to participate in the study.
|
|
General experience
Time Frame: One week post-intervention.
|
Open-ended, free text.
|
One week post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2025
Primary Completion (Actual)
June 8, 2025
Study Completion (Actual)
June 16, 2025
Study Registration Dates
First Submitted
March 24, 2025
First Submitted That Met QC Criteria
March 31, 2025
First Posted (Actual)
April 8, 2025
Study Record Updates
Last Update Posted (Actual)
June 18, 2025
Last Update Submitted That Met QC Criteria
June 17, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ER/GF221/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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