Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT03536520
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-10', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group', 'timeFrame': "Day 2 at 760m and 3'100m", 'description': 'Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group'}], 'secondaryOutcomes': [{'measure': 'Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m', 'timeFrame': "Day 1 and 2 at 760 m and at 3'100m", 'description': 'Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m in the placebo and in the acetazolamide group'}, {'measure': 'Change in arterial oxygen saturation', 'timeFrame': "Day 1 and 2 at 760 m and at 3'100m", 'description': 'Difference in altitude-induced change of arterial oxygen saturation from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo group, measured by pulse oxymetry'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['healthy participants older than 40 years', 'cognition', 'visuo-motor learning performance', 'prevention', 'acetazolamide'], 'conditions': ['Altitude Hypoxia']}, 'referencesModule': {'references': [{'pmid': '36662903', 'type': 'DERIVED', 'citation': 'Reiser AE, Furian M, Lichtblau M, Buergin A, Schneider SR, Appenzeller P, Mayer L, Muralt L, Mademilov M, Abdyraeva A, Aidaralieva S, Muratbekova A, Akylbekov A, Sheraliev U, Shabykeeva S, Sooronbaev TM, Ulrich S, Bloch KE. Effect of acetazolamide on visuomotor performance at high altitude in healthy people 40 years of age or older-RCT. PLoS One. 2023 Jan 20;18(1):e0280585. doi: 10.1371/journal.pone.0280585. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Randomized, placebo controlled trial evaluating the effect of acetazolamide on visuo-motor learning performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.", 'detailedDescription': "This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on visuo-motor learning performance in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.\n\nAn interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women, age 40-75 yrs, without any disease and need of medication.\n* Born, raised and currently living at low altitude (\\<800m).\n* Written informed consent.\n* Kyrgyz ethnicity\n\nExclusion Criteria:\n\n* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.\n* Any condition that may interfere with protocol compliance including current heavy smoking (\\>20 cigarettes per day or \\>20 pack-years with active smoking during the last 10 years), regular use of alcohol.\n* Allergy to acetazolamide and other sulfonamides.'}, 'identificationModule': {'nctId': 'NCT03536520', 'briefTitle': 'Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial', 'orgStudyIdInfo': {'id': '2018-01-8/305D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACETAZOLAMIDE oral capsule', 'description': "Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m", 'interventionNames': ['Drug: ACETAZOLAMIDE oral capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO oral capsule', 'description': "Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m", 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'ACETAZOLAMIDE oral capsule', 'type': 'DRUG', 'description': "Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m", 'armGroupLabels': ['ACETAZOLAMIDE oral capsule']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': "Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m", 'armGroupLabels': ['PLACEBO oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center of Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Konrad E Bloch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Zürich'}, {'name': 'Talant M Sooronbaev, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan'}, {'name': 'Michael Furian, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}