NCT05936684

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2023

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

First Submitted

Initial submission to the registry

June 21, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

January 9, 2025

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

June 21, 2023

Last Update Submit

January 8, 2025

Conditions

Quality of LifeBehaviorStress, Psychological

Keywords

BreathingRelaxationDecision-MakingStress Management

Outcome Measures

Primary Outcomes (5)

  • Behavior: Risk propensity

    Risk propensity, i.e., the willingness to accept or reject a risky mixed gamble in an adapted paradigm based on Tom et al. (2007); assessed using response options "strongly accept", "weakly accept", "weakly reject", "strongly reject"

    1 year

  • Brain: blood-oxygen-level-dependent (BOLD) signal changes

    BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI

    1 year

  • Body: Heart-rate variability

    Low-frequency and high-frequency heart rate variability (LF-HRV and HF-HRV, respectively); assessed using an electrocardiogram (ECG) and pulse oximetry

    1 year

  • Body: Pupil

    Miosis/mydriasis, i.e., changes in pupil dilation; assessed with eye tracking

    1 year

  • Body: Electrodermal activity

    Tonic electrodermal activity (EDA); assessed using a galvanic skin response module

    1 year

Secondary Outcomes (12)

  • Questionnaire assessing depression: "Beck Depression Inventory" (BDI)

    1 year

  • Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)

    1 year

  • Questionnaire assessing impulsivity: "Barratt Impulsivity Scale" (BIS-15)

    1 year

  • Questionnaire assessing approach-avoidance behavior: "Behavioral Inhibition System/Behavioral Approach System" (BIS/BAS)

    1 year

  • Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)

    1 year

  • +7 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

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.

Also known as: ProlEx (decision-making), Slow Breathing
Effect of Eupnea breathing on decision-making if applied before the ProlEx conditionEffect of ProlEx breathing on decision-making if applied before the Eupnea condition
Normal breathing (Eupnea/Control) during risky decision-makingBEHAVIORAL

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.

Also known as: Eupnea (decision-making), Normal Breathing
Effect of Eupnea breathing on decision-making if applied before the ProlEx conditionEffect of ProlEx breathing on decision-making if applied before the Eupnea condition

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Institute of Human Nutrition

Nuthetal, Germany

Location

Related Publications (10)

  • 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.

    BACKGROUND

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

    BACKGROUND

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

    PMID: 1770969BACKGROUND

  • 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

    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)

    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.

    PMID: 30513087BACKGROUND

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

    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

    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.

    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.

    PMID: 17255512BACKGROUND

MeSH Terms

Conditions

BehaviorStress, PsychologicalRespiratory Aspiration

Interventions

Respiration

Condition Hierarchy (Ancestors)

Behavioral SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Soyoung Q Park, Prof. Dr.

    German Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 10, 2023

Study Start

July 4, 2023

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

January 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)