Breathing and Decision-Making (ProlEx-Context)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorGerman Institute of Human Nutrition
About this trial
The ProlEx-Context study aims to investigate how a slow-paced breathing technique with prolonged exhalation affects decision-making in the context of acute social stress.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18- to 40-year-old men and women
Consent to participate
Fluent in German
Right-handed
Disqualifiers
Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
Heart or blood circulation
Lung Diseases
Other serious past or present medical conditions (for example, metabolic syndrome, diabetes)
Trial design
Design model
Crossover
Treatments tested in this trial
Instructed Prolonged Exhalation
BehavioralParticipants are required to perform a specific instructed breathing pattern directed by visual cues. The core characteristic is a systematic lengthening of the expiratory phase relative to the inspiratory phase. Specifically, participants are instructed to inhale for 2 seconds and prolong their exhalation to 8 seconds.
Instructed Individualized Eupnea
BehavioralInstructed Individualized Eupnea: In this control condition, participants are instructed to match their breath to a visual cue that is calibrated to their own characteristic natural respiratory frequency. This frequency is sampled during representative non-interventional phases of the session to capture the participant's individual baseline eupnea pace within the experimental context.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Prolonged Exhalation BreathingExperimental treatment 1 intervention
Group B: Eupnea Breathing (Normal)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Risk propensity
The dependent variable will be trial-wise gamble acceptance (accept vs. reject of a 50% gamble), which will be mainly analyzed using a binomial generalized linear mixed-effects model (GLMM) to compare the Prolonged Exhalation and Eupnea conditions under acute stress.
Time frame
On day 1.2
Task-related BOLD Signals
Task-related changes in blood-oxygen-level-dependent (BOLD) signals measured using functional magnetic resonance imaging (fMRI).
Time frame
On day 1.3
Structural T1-weighted MRI
High-resolution T1-weighted structural images measured using magnetic resonance imaging (MRI).
Time frame
On day 1.4
Relative amplitude of the respiratory signal
Task-based and resting-state relative respiratory amplitude, measured via a respiratory belt and nasal airflow sensor.
Time frame
On day 1.Secondary outcomes
1
Response Times
The average time (in milliseconds) taken by participants to make a choice in each trial.
Time frame
On day 1.2
Self-reported levels of stress
Self-reported levels of stress will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."
Time frame
On day 1.3
Self-reported levels of tension
Self-reported levels of tension will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."
Time frame
On day 1.4
Self-reported levels of heart feeling
Self-reported levels of heart feeling will be measured via a Visual Analog Scale (VAS) ranging from 0 to 100. A score of 0 represents "not at all" and 100 represents "extremely high."
Time frame
On day 1.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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