StressNCT06986135
The Effect of Breathing on Cognitive Performance and Stress
A study testing Box Breathing, Prolonged Exhalation and Normal Breathing in people with Stress and Acute Stress Reaction, run by Texas State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Acute Stress Reaction, Breathing Techniques
- What is being tested?
- Box Breathing, Prolonged Exhalation and Normal Breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Between the ages of 18-39,
- Student at Texas State.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas State University, Metabolic & Applied Physiology Lab
San Marcos, Texas, 78666
About this study
Official title: The Effect of Breathing Interventions on Biomarkers of Stress and Cognitive Performance Following a Psychologically Stressful Task
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.
Read the detailed description
This study examined the effect of three various breathing techniques (i.e., normal breathing, prolonged exhalation, and box breathing) on biomarkers of stress and mental performance after the Trier Social Stress Test (TSST). The TSST has been shown to result in significant increases in psychological and physiological stress markers. Therefore, the goal of this study was to examine potential interventions to mitigate the effects of this psychological stressor while maintaining increased cognitive performance. Moreover, previous literature has shown various effects of breathing interventions, therefore, the investigators wished to further validate breathing techniques as an effective tool to mitigate stress and increase cognitive performance. The data from this research provided insight to real life events, allowing for a principal understanding of how to reduce stress, focused at first responder populations.
- Being tested
- Box Breathing, Prolonged Exhalation, Normal Breathing
- Keywords
- Stress, Trier Social Stress Test, Acute Stress, Breathing Technique, Box Breathing, Cognitive Performance, Biomarkers
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box BreathingOther
Box breathing consisted of a 4 second inhale, 4 second hold, 4 second exhale, 4 second hold; for 4 minutes.
Prolonged ExhalationOther
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.
Normal BreathingOther
This was the placebo, normal breathing group was instructed to breath as they normally would for the entirety of the 4 minute period.
| Study group | Role | What they receive |
|---|---|---|
| Box Breathing group | Experimental | Group to be assigned box breathing. Receives: Other: Box Breathing |
| Prolonged Exhalation Breathing assignment group | Experimental | Breathing group to be assigned the prolonged exhalation intervention. Receives: Other: Prolonged Exhalation |
| Placebo (normal breathing) group | Placebo comparator | This group is not assigned a breathing technique, and acts as a placebo. Receives: Other: Normal Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Aug 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects were randomly assigned to one of three groups, between and within subject analysis occurred.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas State University, San Marcos
- Responsible party
- Principal investigator, Matt McAllister, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986135
- Sponsor's protocol ID
- IRB #9665
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IRB at Texas State does not allow the sharing of individual data, and all data has already been made unidentifiable for this study.
Publications
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.
PubMed 18778321Allen 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.
PubMed 28229114Matsumoto 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.
PubMed 21763472Narkiewicz 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.
PubMed 16344363Ntovas 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.
PubMed 35049605Dillard 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.
PubMed 37628548Kim 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.
PubMed 29486547
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Interventions on Biomarkers of Stress and Cognitive Performance Following a Psychologically Stressful Task
- ClinicalTrials.gov ID
- NCT06986135
- Acronym / sponsor ID
- IRB #9665
- Keywords
- Stress, Trier Social Stress Test, Acute Stress, Breathing Technique, Box Breathing, Cognitive Performance, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Collaborators
- Texas State University, San Marcos
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study examined the effect of three various breathing techniques (i.e., normal breathing, prolonged exhalation, and box breathing) on biomarkers of stress and mental performance after the Trier Social Stress Test (TSST). The TSST has been shown to result in significant increases in psychological and physiological stress markers. Therefore, the goal of this study was to examine potential interventions to mitigate the effects of this psychological stressor while maintaining increased cognitive performance. Moreover, previous literature has shown various effects of breathing interventions, therefore, the investigators wished to further validate breathing techniques as an effective tool to mitigate stress and increase cognitive performance. The data from this research provided insight to real life events, allowing for a principal understanding of how to reduce stress, focused at first responder populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Subjects were randomly assigned to one of three groups, between and within subject analysis occurred.
| Arm | Type | Receives |
|---|---|---|
| Box Breathing group | Experimental | Other: Box BreathingGroup to be assigned box breathing. |
| Prolonged Exhalation Breathing assignment group | Experimental | Other: Prolonged ExhalationBreathing group to be assigned the prolonged exhalation intervention. |
| Placebo (normal breathing) group | Placebo comparator | Other: Normal BreathingThis group is not assigned a breathing technique, and acts as a placebo. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy
- Between the ages of 18-39,
- Student at Texas State.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Box BreathingBox breathing consisted of a 4 second inhale, 4 second hold, 4 second exhale, 4 second hold; for 4 minutes. | Other | Box Breathing group |
| Prolonged ExhalationProlonged 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. | Other | Prolonged Exhalation Breathing assignment group |
| Normal BreathingThis was the placebo, normal breathing group was instructed to breath as they normally would for the entirety of the 4 minute period. | Other | Placebo (normal breathing) group |
Primary outcome
Cognitive Challenge
Time frame: 20 minutes prior to TSST start and immediately post TSST.
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.
Heart Rate
Time frame: HR was recorded 4 times, during each saliva sample collection period
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.
State Anxiety Inventory (SAI)
Time frame: Timepoint 1-4, 40 minutes pre, 10 minutes pre, immediately post, 25 minutes post.
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.
Heart rate variability
Time frame: HRV was recorded immediately following the 2nd, 3rd, and 4th saliva samples.
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.
Secretory Immunoglobin-A
Time frame: 40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST
SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress
Salivary Alpha Amylase
Time frame: 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Results publication: PubMed 18778321Kotlyar 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.
- Results publication: PubMed 28229114Allen 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.
- Results publication: PubMed 21763472Matsumoto 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.
- Results publication: PubMed 16344363Narkiewicz 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.
- Results publication: PubMed 35049605Ntovas 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.
- Results publication: PubMed 37628548Dillard 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.
- Results publication: PubMed 29486547Kim 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.
- Individual participant dataSharing planned: No. IRB at Texas State does not allow the sharing of individual data, and all data has already been made unidentifiable for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing, Prolonged Exhalation and Normal Breathing in people with Stress and Acute Stress Reaction, run by Texas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Challenge (time frame: 20 minutes prior to TSST start and immediately post TSST.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986135, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.