Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-02 @ 5:32 AM
Study NCT ID:
NCT06986135
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Breathing on Cognitive Performance and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040701', 'term': 'Stress Disorders, Traumatic, Acute'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects were randomly assigned to one of three groups, between and within subject analysis occurred.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Challenge', 'timeFrame': '20 minutes prior to TSST start and immediately post TSST.', 'description': '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.'}, {'measure': 'Heart Rate', 'timeFrame': 'HR was recorded 4 times, during each saliva sample collection period', 'description': '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.'}, {'measure': 'State Anxiety Inventory (SAI)', 'timeFrame': 'Timepoint 1-4, 40 minutes pre, 10 minutes pre, immediately post, 25 minutes post.', 'description': '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.'}, {'measure': 'Heart rate variability', 'timeFrame': 'HRV was recorded immediately following the 2nd, 3rd, and 4th saliva samples.', 'description': '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.'}, {'measure': 'Secretory Immunoglobin-A', 'timeFrame': '40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST', 'description': 'SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress'}, {'measure': 'Salivary Alpha Amylase', 'timeFrame': '40 minutes prior to modified TSST start, 10 minutes prior to modified TSST start, immediately post modified TSST, and 25 minutes post TSST', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'Trier Social Stress Test', 'Acute Stress', 'Breathing Technique', 'Box Breathing', 'Cognitive Performance', 'Biomarkers'], 'conditions': ['Stress', 'Acute Stress Reaction', 'Breathing Techniques', 'Cognitive Performance']}, 'referencesModule': {'references': [{'pmid': '18778321', 'type': 'BACKGROUND', 'citation': "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': '28229114', 'type': 'BACKGROUND', 'citation': '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': '21763472', 'type': 'BACKGROUND', 'citation': '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': '16344363', 'type': 'BACKGROUND', 'citation': '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': '35049605', 'type': 'BACKGROUND', 'citation': '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': '37628548', 'type': 'BACKGROUND', 'citation': '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': '29486547', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Between the ages of 18-39,\n* Student at Texas State.\n\nExclusion Criteria:\n\n* Any known cardiovascular or metabolic disease\n* Consuming any medication for psychiatric disorders (i.e., anxiety, depression, ADHD)\n* Being diagnosed with any psychiatric or physical conditions\n* Any major stressors in the last 30 days (i.e., birth of a child, abortion, divorce).'}, 'identificationModule': {'nctId': 'NCT06986135', 'briefTitle': 'The Effect of Breathing on Cognitive Performance and Stress', 'organization': {'class': 'OTHER', 'fullName': 'Texas State University'}, 'officialTitle': 'The Effect of Breathing Interventions on Biomarkers of Stress and Cognitive Performance Following a Psychologically Stressful Task', 'orgStudyIdInfo': {'id': 'IRB #9665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Box Breathing group', 'description': 'Group to be assigned box breathing.', 'interventionNames': ['Other: Box Breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Prolonged Exhalation Breathing assignment group', 'description': 'Breathing group to be assigned the prolonged exhalation intervention.', 'interventionNames': ['Other: Prolonged Exhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (normal breathing) group', 'description': 'This group is not assigned a breathing technique, and acts as a placebo.', 'interventionNames': ['Other: Normal Breathing']}], 'interventions': [{'name': 'Box Breathing', 'type': 'OTHER', 'description': 'Box breathing consisted of a 4 second inhale, 4 second hold, 4 second exhale, 4 second hold; for 4 minutes.', 'armGroupLabels': ['Box Breathing group']}, {'name': 'Prolonged Exhalation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Prolonged Exhalation Breathing assignment group']}, {'name': 'Normal Breathing', 'type': 'OTHER', 'description': 'This was the placebo, normal breathing group was instructed to breath as they normally would for the entirety of the 4 minute period.', 'armGroupLabels': ['Placebo (normal breathing) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas State University, Metabolic & Applied Physiology Lab', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IRB at Texas State does not allow the sharing of individual data, and all data has already been made unidentifiable for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas State University, San Marcos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matt McAllister', 'investigatorAffiliation': 'Texas State University'}}}}