NCT06916312

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

March 24, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Breathwork

Outcome Measures

Primary Outcomes (3)

  • Altered states of consciousness

    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

    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

    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 Outcomes (6)

  • Psychological insight

    Post-intervention (one week after the intervention).

  • Depersonalisation

    Immediately after the intervention.

  • Fatigue

    Baseline and post-intervention (one week before and after the intervention).

  • Sleep-related impairment

    Baseline and post-intervention (one week before and after the intervention).

  • Mental wellbeing

    Baseline and post-intervention (one week before and after the intervention).

  • +1 more secondary outcomes

Other Outcomes (2)

  • Psychedelic experience predictiveness

    After completing consent form to participate in the study.

  • General experience

    One week post-intervention.

Study Arms (2)

Meditation

ACTIVE COMPARATOR

Single guided body scan meditation session.

Behavioral: Meditation

High ventilation breathwork

EXPERIMENTAL

Single guided conscious connected breathing session.

Behavioral: High ventilation breathwork

Interventions

Single guided conscious connected breathing session.

Also known as: Conscious connected breathing
High ventilation breathwork
MeditationBEHAVIORAL

Single guided body scan meditation session.

Also known as: Body scan
Meditation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sussex

Brighton, Sussex, BN1 9RH, United Kingdom

Location

MeSH Terms

Interventions

MeditationWhole Body Imaging

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 8, 2025

Study Start

February 17, 2025

Primary Completion

June 8, 2025

Study Completion

June 16, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations