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Breathing and Decision-Making (ProlEx-MRI)

G

German Institute of Human Nutrition

Status

Completed

Conditions

Behavior
Quality of Life
Stress, Psychological

Treatments

Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making
Behavioral: Normal breathing (Eupnea/Control) during risky decision-making

Study type

Interventional

Funder types

Other

Identifiers

NCT05936684
ProlEx-MRI

Details and patient eligibility

About

The study aims to investigate how slow breathing with prolonged exhalation (i.e., ProlEx breathing) modulates decision-making under risk in healthy participants. To do this, a short-term breathing intervention is combined with a decision-making paradigm while neural, physiological, and behavioral data are recorded.

Full description

This interventional study investigates the modulatory effect of slow breathing with prolonged exhalation (i.e., ProlEx breathing) on decision-making under risk. Using functional magnetic resonance imaging (fMRI), the researchers seek to identify brain regions influenced by the breathing intervention during the decision-making task.

Sixty healthy participants will be invited to perform ProlEx breathing during a risky decision-making task. After initial preparations, each individual's spontaneous breathing rhythm will be determined (i.e., Eupnea, control condition). This step is to i) ensure a natural breathing pace for each participant and ii) incorporate cue-assisted breathing into the control condition to allow comparability across conditions. To further investigate the effect of ProlEx on sympathovagal tone, physiological measures of respiration, electrocardiogram, pulse, electrodermal activity, and pupil are acquired. During scanning, the participant will perform a decision-making task based on the paradigm by Tom et al. (2007). The breathing intervention is applied simultaneously with continuous cue-assisted breathing for both conditions (Eupnea, ProlEx) throughout the duration of the task. The experiment follows a block design with counterbalanced orders to control for confounding effects. After completion of the scans, the participants fill out additional questionnaires.

Enrollment

53 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy men and women
  • Normal vision (no glasses or contact lenses required)

Exclusion criteria

  • Smokers
  • Extreme athletes
  • Extensive lung function (e.g., professional musician, abnoedivers)
  • Excessive stress
  • Former or current physical or psychological illness (e.g., lung diseases)
  • Current or previous medication within 2 weeks before the appointment
  • Left-handedness
  • Claustrophobia
  • Tinnitus
  • Non-removable metal parts or implants inside or on the body (e.g., hip replacements, copper IUD)
  • Non-removable ferromagnetic objects inside or on the body (e.g., joint replacements)
  • Non-removable magnetic objects inside or on the body (e.g., artificial eye)
  • Large tattoos
  • Young (>18 years) or old (>40 years) subjects
  • Over- or underweight (BMI <18 or >25 kg/m2)
  • Pregnancy
  • Abnormal circadian rhythm (e.g., during shift work)
  • Excessive alcohol consumption
  • Illegal drug consumption within 2 weeks before the appointment
  • Missing consent to participate
  • Missing consent to receive incidental findings (MRI)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

53 participants in 2 patient groups

Effect of ProlEx breathing on decision-making if applied before the Eupnea condition
Experimental group
Description:
Intervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making
Treatment:
Behavioral: Normal breathing (Eupnea/Control) during risky decision-making
Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making
Effect of Eupnea breathing on decision-making if applied before the ProlEx condition
Experimental group
Description:
Intervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making
Treatment:
Behavioral: Normal breathing (Eupnea/Control) during risky decision-making
Behavioral: Breathing with prolonged exhalation (ProlEx) during risky decision-making

Trial contacts and locations

1

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Central trial contact

Bianca Weigel

Data sourced from clinicaltrials.gov

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