Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT02450994
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, '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': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-18', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 1 at 3200 m', 'description': 'Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group'}], 'secondaryOutcomes': [{'measure': 'Oxygen desaturation index', 'timeFrame': 'night 1 at 3200 m', 'description': 'Difference in oxygen desaturation index (\\>3%) between dexamethasone and placebo group'}, {'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 2 at 3200 m', 'description': 'Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group'}, {'measure': 'Apnea/hypopnea index', 'timeFrame': 'night 2 at 3200 m', 'description': 'Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group'}, {'measure': 'Apnea/hypopnea index', 'timeFrame': 'night 1 at 3200 m', 'description': 'Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group'}, {'measure': 'Oxygen desaturation index', 'timeFrame': 'night 2 at 3200 m', 'description': 'Difference in oxygen desaturation index (\\>3%) between dexamethasone and placebo group'}, {'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 1 at 700 m', 'description': 'Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group'}, {'measure': 'Oxygen desaturation index', 'timeFrame': 'night 1 at 700 m', 'description': 'Difference in oxygen desaturation index (\\>3%) between dexamethasone and placebo group'}, {'measure': 'Apnea/hypopnea index', 'timeFrame': 'night 1 at 700 m', 'description': 'Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group'}, {'measure': 'Psychomotor vigilance test reaction time', 'timeFrame': 'day 2 at 700 m', 'description': 'Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group'}, {'measure': 'Subjective sleepiness', 'timeFrame': 'day 2 at 700 m', 'description': 'Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group'}, {'measure': 'Subjective sleepiness', 'timeFrame': 'day 2 at 3200 m', 'description': 'Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['airway disease', 'bronchitis', 'emphysema', 'lung', 'treatment', 'sleep'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '30794302', 'type': 'DERIVED', 'citation': 'Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2\n* Living at low altitude (\\<800m)\n\nExclusion Criteria:\n\n* COPD exacerbation\n* severe COPD, GOLD grade 3 or 4\n* arterial oxygen saturation \\<92% at low altitude (\\<800 m)\n* Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.\n* Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\\>20 cigarettes per day).\n* pregnant or nursing patients'}, 'identificationModule': {'nctId': 'NCT02450994', 'briefTitle': 'Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude', 'orgStudyIdInfo': {'id': 'EK15-2015_V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone 4 mg capsules, twice per day, orally', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules twice per day, orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, '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'}]}, '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'}}}}