Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 3:32 AM
Study NCT ID:
NCT07126834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voluntary Isocapnic Hyperpnea in Hypoxia to Mitigate Acute Mountain Sickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D006985', 'term': 'Hyperventilation'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO₂', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': 'Arterial oxygen saturation (SpO₂)'}, {'measure': 'AMS LL', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': '2018 Lake Louise Acute Mountain Sickness Score'}, {'measure': 'pH', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': 'hydrogen ion concentration'}, {'measure': 'pO₂', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': 'partial pressure of oxygen (pO₂)'}, {'measure': 'pCO₂', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': 'partial pressure of carbon dioxide (pCO₂)'}, {'measure': 'HCO₃-', 'timeFrame': 'Day 1 and Day 2 of the study.', 'description': 'bicarbonate ion concentration (HCO₃-)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute mountan sickness', 'breathing', 'hyperpnoea', 'blood gas analysis', 'lake louis scale'], 'conditions': ['Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of a brief Voluntary Isocapnic Hyperpnoea (VIH) on Acute Mountain Sickness (AMS) symptoms, SpO₂, blood pressure, and blood gas homeostasis in normobaric hypoxia, to evaluate whether such respiratory modulation may serve as a viable strategy to alleviate AMS symptoms. The investigation seeks to explore the physiological mechanisms underlying VIH in severe hypoxia (4200m asl) and furnish insight regarding practical means of providing immediate relief from AMS symptoms. Furthermore, given the scarcity of relevant literature, this investigation may serve as a pilot study and lay the foundation for future research.\n\nThe present investigation employed a randomized crossover design. The study was conducted in the Institute of Sport - National Research Institute in Warsaw, Poland, in July and August 2025. Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. The order of sessions was determined using block randomization within subgroups of 4-6 individuals to ensure balanced exposure to each condition. Multiple measurements were taken, including blood pressure, heart rate, SpO2, blood gasometry, and the 2018 Lake Louise AMS Score.', 'detailedDescription': "Blood gas analysis was conducted using a Radiometer™ ABL90 FLEX (Radiometer Medical ApS, Brønshøj, Denmark). The following parameters were assessed: hydrogen ion concentration (pH), bicarbonate ion concentration (HCO₃-), partial pressure of oxygen (pO₂), and partial pressure of carbon dioxide (pCO₂). All measurements were taken in duplicate using 45 µL capillary blood samples collected from the fingertip. Analyses were performed immediately following collection by a trained technician following the manufacturer's instructions.\n\nPeripheral blood pressure was measured digitally using the OMRON M2 monitor (OMRON Healthcare, Kyoto, Japan).\n\nSpO₂ was estimated at the fingertip using a pulse oximeter (NONIN Onyx Vantage 9590, Nonin Medical, Inc., Plymouth, MN, USA).\n\nThe 2018 Lake Louise AMS Score questionnaire was presented to the participants before the experiment for familiarization and then used to evaluate symptoms of AMS based on a combination of subjective self-reports and clinical findings.\n\nAll the measurements were performed by qualified and experienced specialists. The participants were blinded to the obtained results, except for the 2018 Lake Louise AMS Score, which was self-reported."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "The inclusion criteria comprised:\n\n* age between 18 and 39 years,\n* meeting the World Health Organization's minimum physical activity guidelines, defined as 150-300 minutes of moderate-intensity aerobic activity per week, 75-150 minutes of vigorous-intensity activity, or an equivalent combination of both (Bull et al. 2020).\n\nExclusion criteria included:\n\n* exposure to hypoxia within the past three months,\n* any chronic or acute medical condition within the same timeframe,\n* current use of any medication,\n* known allergic reactions,\n* pregnancy,\n* smoking."}, 'identificationModule': {'nctId': 'NCT07126834', 'briefTitle': 'Voluntary Isocapnic Hyperpnea in Hypoxia to Mitigate Acute Mountain Sickness', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Sport - National Research Institute, Poland'}, 'officialTitle': 'Could a Breathing Protocol Serve as a Non-Pharmacological Strategy to Mitigate Acute Mountain Sickness? A Randomized Crossover Trial.', 'orgStudyIdInfo': {'id': '2025/TK/1'}, 'secondaryIdInfos': [{'id': '102.39/2025', 'type': 'OTHER_GRANT', 'domain': 'Institute of Sport-National Research Institute, Poland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration.', 'interventionNames': ['Behavioral: VIH']}], 'interventions': [{'name': 'VIH', 'type': 'BEHAVIORAL', 'description': 'During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-982', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Institute of Sport - National Research Institute, Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy reasons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Sport - National Research Institute, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Research Associate', 'investigatorFullName': 'Tomasz Kowalski', 'investigatorAffiliation': 'Institute of Sport - National Research Institute, Poland'}}}}