NCT06986135

Brief Summary

The purpose of this study is to determine the effectiveness of different breathing techniques on biomarkers of stress and cognitive performance following the Trier Social Stress Test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 7, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

StressTrier Social Stress TestAcute StressBreathing TechniqueBox BreathingCognitive PerformanceBiomarkers

Outcome Measures

Primary Outcomes (6)

  • Cognitive Challenge

    Subjects participated in a 1 minute familiarization for the Stroop Color Word Challenge, followed by a full 2 minute Stroop Color Word challenge. Immediately following the Stroop, subjects then participated in a 2 minute mental arithmetic. The Stroop consisted of conflicting color-word fonts, and the subject had to choose the correct font color: subjects had .5 seconds to respond to each answer utilizing a color coordinated keypad. The mental arithmetic consisted of a series of mathematical problems (i.e., one, two, or three digit addition and subtraction). If subjects got an answer wrong for the mental math, a buzzer would sound.

    20 minutes prior to TSST start and immediately post TSST.

  • Heart Rate

    Heart rate was recorded immediately prior to each saliva sample using the same tools to record the HRV measure. The Polar H10 and HRVTrace app was utilized to record a Heart rate measure 4 times throughout the study.

    HR was recorded 4 times, during each saliva sample collection period

  • State Anxiety Inventory (SAI)

    The SAI is a 6 question survey on a 24 point scale, asking the subject to record how they feel. Questions asked were "I am calm", "I am tense", "I am worried", "I am relaxed", etc. Subjects were asked to fill this out 4 times throughout the study, alongside the HR and saliva samples.

    Timepoint 1-4, 40 minutes pre, 10 minutes pre, immediately post, 25 minutes post.

  • Heart rate variability

    Heart Rate Variability (HRV) was measured three times over the course of the study in order to measure responses to stress. A Polar H10 monitor was used, alongside the HRVTrace app to record the three measures. Each HRV measurement was 7 minutes, and required the subjects to sit quietly and watch a standardized nature video.

    HRV was recorded immediately following the 2nd, 3rd, and 4th saliva samples.

  • Secretory Immunoglobin-A

    SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress

    40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST

  • Salivary Alpha Amylase

    salivary alpha amylase is an enzyme involved in digestive processes. Amylase concentration in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary amylase concentrations tend to increase.

    40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST

Study Arms (3)

Box Breathing group

EXPERIMENTAL

Group to be assigned box breathing.

Other: Box Breathing

Prolonged Exhalation Breathing assignment group

EXPERIMENTAL

Breathing group to be assigned the prolonged exhalation intervention.

Other: Prolonged Exhalation

Placebo (normal breathing) group

PLACEBO COMPARATOR

This group is not assigned a breathing technique, and acts as a placebo.

Other: Normal Breathing

Interventions

Box breathing consisted of a 4 second inhale, 4 second hold, 4 second exhale, 4 second hold; for 4 minutes.

Box Breathing group

Prolonged Exhalation consisted of a deep, 3 second inhale, followed by a slow 6 second exhale through pursed lips, once every 30 seconds for 4 minutes.

Prolonged Exhalation Breathing assignment group

This was the placebo, normal breathing group was instructed to breath as they normally would for the entirety of the 4 minute period.

Placebo (normal breathing) group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy
  • Between the ages of 18-39,
  • Student at Texas State.

You may not qualify if:

  • Any known cardiovascular or metabolic disease
  • Consuming any medication for psychiatric disorders (i.e., anxiety, depression, ADHD)
  • Being diagnosed with any psychiatric or physical conditions
  • Any major stressors in the last 30 days (i.e., birth of a child, abortion, divorce).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas State University, Metabolic & Applied Physiology Lab

San Marcos, Texas, 78666, United States

Location

Related Publications (7)

  • Kotlyar M, Donahue C, Thuras P, Kushner MG, O'Gorman N, Smith EA, Adson DE. Physiological response to a speech stressor presented in a virtual reality environment. Psychophysiology. 2008 Nov;45(6):1034-7. doi: 10.1111/j.1469-8986.2008.00690.x. Epub 2008 Sep 4.

    PMID: 18778321BACKGROUND
  • Allen AP, Kennedy PJ, Dockray S, Cryan JF, Dinan TG, Clarke G. The Trier Social Stress Test: Principles and practice. Neurobiol Stress. 2016 Nov 12;6:113-126. doi: 10.1016/j.ynstr.2016.11.001. eCollection 2017 Feb.

    PMID: 28229114BACKGROUND
  • Matsumoto T, Masuda T, Hotta K, Shimizu R, Ishii A, Kutsuna T, Yamamoto K, Hara M, Takahira N, Matsunaga A. Effects of prolonged expiration breathing on cardiopulmonary responses during incremental exercise. Respir Physiol Neurobiol. 2011 Sep 15;178(2):275-82. doi: 10.1016/j.resp.2011.06.025. Epub 2011 Jul 7.

    PMID: 21763472BACKGROUND
  • Narkiewicz K, van de Borne P, Montano N, Hering D, Kara T, Somers VK. Sympathetic neural outflow and chemoreflex sensitivity are related to spontaneous breathing rate in normal men. Hypertension. 2006 Jan;47(1):51-5. doi: 10.1161/01.HYP.0000197613.47649.02. Epub 2005 Dec 12.

    PMID: 16344363BACKGROUND
  • Ntovas P, Loumprinis N, Maniatakos P, Margaritidi L, Rahiotis C. The Effects of Physical Exercise on Saliva Composition: A Comprehensive Review. Dent J (Basel). 2022 Jan 5;10(1):7. doi: 10.3390/dj10010007.

    PMID: 35049605BACKGROUND
  • Dillard CC, Martaindale H, Hunter SD, McAllister MJ. Slow Breathing Reduces Biomarkers of Stress in Response to a Virtual Reality Active Shooter Training Drill. Healthcare (Basel). 2023 Aug 21;11(16):2351. doi: 10.3390/healthcare11162351.

    PMID: 37628548BACKGROUND
  • Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.

    PMID: 29486547BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Subjects were randomly assigned to one of three groups, between and within subject analysis occurred.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 22, 2025

Study Start

August 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

IRB at Texas State does not allow the sharing of individual data, and all data has already been made unidentifiable for this study.

Locations