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临床试验/NCT05936684
NCT05936684已完成不适用

Breathing and Decision-Making: an FMRI Study Investigating the Link Between Slow Breathing and Risky Decision-Making

German Institute of Human Nutrition1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2023年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Body: Pupil

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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
  • •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)

研究组 & 干预措施

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

干预措施: Breathing with prolonged exhalation (ProlEx) during risky decision-making (Behavioral)

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

干预措施: Normal breathing (Eupnea/Control) during risky decision-making (Behavioral)

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

干预措施: Breathing with prolonged exhalation (ProlEx) during risky decision-making (Behavioral)

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

干预措施: Normal breathing (Eupnea/Control) during risky decision-making (Behavioral)

结局指标

主要结局

Body: Pupil

时间窗: 1 year

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

Body: Electrodermal activity

时间窗: 1 year

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

Behavior: Risk propensity

时间窗: 1 year

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"

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

时间窗: 1 year

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

Body: Heart-rate variability

时间窗: 1 year

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

次要结局

  • Questionnaire assessing affect: "Positive and Negative Affect Scale" (PANAS)(1 year)
  • Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)(1 year)
  • Questionnaire assessing interoceptive awareness: "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2)(1 year)
  • Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)(1 year)
  • Questionnaire assessing depression: "Beck Depression Inventory" (BDI)(1 year)
  • Questionnaire assessing self-efficacy: "General Self-Efficacy Scale" (GSE)(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 stress: "Perceived Stress Questionnaire" (PSQ)(1 year)
  • Questionnaire assessing anxiety: "State-Trait Anxiety Inventory" (STAI-T)(1 year)
  • Questionnaire assessing mentall well-being: "Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)(1 year)
  • Body: Eye gaze(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Soyoung Q Park

Prof. Dr.

German Institute of Human Nutrition

研究点 (1)

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