Breathing and Decision-Making

NCT ID: NCT05936684

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2024-09-25

Brief Summary

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.

Detailed 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.

Conditions

Quality of Life; Behavior; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Effect of ProlEx breathing on decision-making if applied before the Eupnea condition

Intervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making

Group Type: EXPERIMENTAL

Breathing with prolonged exhalation (ProlEx) during risky decision-making

Intervention Type: BEHAVIORAL

20 min divided in 3 blocks of slow, 0.1 Hz breathing (6 cycles per minute) with an inhalation-to-exhalation ratio of 2:8. Cue-assisted breathing (same across participants) and performance of a risky decision-making task (Tom et al., 2007) in the magnetic resonance imaging (MRI) scanner with simultaneous acquisition of physiological and pupil data.

Normal breathing (Eupnea/Control) during risky decision-making

Intervention Type: BEHAVIORAL

20 min divided in 3 blocks of normal breathing (expected range: 0.16-0.33 Hz, i.e., 10-20 per min), Cue-assisted breathing (individually adapted) and performance of a risky decision-making task (Tom et al., 2007) in the MRI scanner with simultaneous acquisition of physiological and pupil data.

Effect of Eupnea breathing on decision-making if applied before the ProlEx condition

Intervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making

Group Type: EXPERIMENTAL

Breathing with prolonged exhalation (ProlEx) during risky decision-making

Intervention Type: BEHAVIORAL

20 min divided in 3 blocks of slow, 0.1 Hz breathing (6 cycles per minute) with an inhalation-to-exhalation ratio of 2:8. Cue-assisted breathing (same across participants) and performance of a risky decision-making task (Tom et al., 2007) in the magnetic resonance imaging (MRI) scanner with simultaneous acquisition of physiological and pupil data.

Normal breathing (Eupnea/Control) during risky decision-making

Intervention Type: BEHAVIORAL

20 min divided in 3 blocks of normal breathing (expected range: 0.16-0.33 Hz, i.e., 10-20 per min), Cue-assisted breathing (individually adapted) and performance of a risky decision-making task (Tom et al., 2007) in the MRI scanner with simultaneous acquisition of physiological and pupil data.

Interventions

Breathing with prolonged exhalation (ProlEx) during risky decision-making

20 min divided in 3 blocks of slow, 0.1 Hz breathing (6 cycles per minute) with an inhalation-to-exhalation ratio of 2:8. Cue-assisted breathing (same across participants) and performance of a risky decision-making task (Tom et al., 2007) in the magnetic resonance imaging (MRI) scanner with simultaneous acquisition of physiological and pupil data.

Intervention Type: BEHAVIORAL

Normal breathing (Eupnea/Control) during risky decision-making

20 min divided in 3 blocks of normal breathing (expected range: 0.16-0.33 Hz, i.e., 10-20 per min), Cue-assisted breathing (individually adapted) and performance of a risky decision-making task (Tom et al., 2007) in the MRI scanner with simultaneous acquisition of physiological and pupil data.

Intervention Type: BEHAVIORAL

Other Intervention Names

ProlEx (decision-making); Slow Breathing; Eupnea (decision-making); Normal Breathing

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

German Center for Diabetes Research

OTHER

Sponsor Role: collaborator

Freie Universität Berlin

OTHER

Sponsor Role: collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Soyoung Q Park

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soyoung Q Park, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Institute of Human Nutrition

Locations

German Institute of Human Nutrition

Nuthetal, , Germany

Countries

Germany

References

Fliege, H., Rose, M., Arck, P., Levenstein, S. & Klapp, B. F. (2001). Validierung des Perceived Stress Questionnaire (PSQ) an einer deutschen Stichprobe. Diagnostica, 47, 142-152.

Reference Type: BACKGROUND

Grimm, J. State-trait-anxiety inventory nach Spielberger. Deutsche Lang- und Kurzversion. Methodenforum der Universität Wien: MF-Working Paper (2009).

Reference Type: BACKGROUND

Hautzinger M. [The Beck Depression Inventory in clinical practice]. Nervenarzt. 1991 Nov;62(11):689-96. German.

Reference Type: BACKGROUND

PMID: 1770969 (View on PubMed)

Janke, S., & Glöckner-Rist, A. (2014). "Deutsche Version der Positive and Negative Affect Schedule (PANAS)" in Zusammenstellung sozialwissenschaftlicher Items und Skalen, GESIS (Mannheim, Germany). doi.org/10.6102/zis146

Reference Type: BACKGROUND

Lang, G. & Bachinger, A. Validation of the German Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) in a community-based sample of adults in Austria: a bi-factor modelling approach. J Public Health 25, 135-146 (2017)

Reference Type: BACKGROUND

Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30513087 (View on PubMed)

Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).

Reference Type: BACKGROUND

Rammstedt, B., Kemper, C.J., Klein, M.C., Beierlein, C., & Kovaleva, A. (2013). Eine kurze Skala zur Mes-sung der fünf Dimensionen der Persönlichkeit. Methoden, Daten, Analysen, 7(2), S. 233-249

Reference Type: BACKGROUND

Schwarzer, R., Bäßler, J., Kwiatek, P., Schröder, K., & Zhang, J. X. (1997). The assessment of optimistic self-beliefs: comparison of the German, Spanish, and Chinese versions of the general self-efficacy scale. Applied Psychology, 46(1), 69-88.

Reference Type: BACKGROUND

Tom SM, Fox CR, Trepel C, Poldrack RA. The neural basis of loss aversion in decision-making under risk. Science. 2007 Jan 26;315(5811):515-8. doi: 10.1126/science.1134239.

Reference Type: BACKGROUND

PMID: 17255512 (View on PubMed)

Other Identifiers

ProlEx-MRI

Identifier Type: -

Identifier Source: org_study_id