Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-02 @ 12:54 AM
Study NCT ID:
NCT05462834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058868', 'term': 'Compressed Air'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000388', 'term': 'Air'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '2 intervention periods lasting 14 days, separated by a 7-day washout'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean glucose level', 'timeFrame': '14 days after start of intervention', 'description': 'average glucose (mg/dL) during sleep assessed via continuous glucose monitoring'}], 'secondaryOutcomes': [{'measure': 'Mean fasting glucose level', 'timeFrame': '14 days after start of intervention', 'description': 'Mean fasting glucose level (mg/dL)'}, {'measure': 'Mean fasting insulin', 'timeFrame': '14 days after start of intervention', 'description': 'Fasting insulin (U/mL)'}, {'measure': 'Morning blood pressure', 'timeFrame': '14 days after start of intervention', 'description': 'Morning blood pressure (mmHg)'}, {'measure': 'Inflammatory marker interleukin-6 (IL-6)', 'timeFrame': '14 days after start of intervention', 'description': 'Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation'}, {'measure': 'Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)', 'timeFrame': '14 days after start of intervention', 'description': 'Tumor Necrosis Factor alpha level in blood as a marker of inflammation'}, {'measure': 'C-Reactive Protein (CRP) level in blood (mg/L)', 'timeFrame': '14 days after start of intervention', 'description': 'C-Reactive Protein (CRP) level in blood as a marker of inflammation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep-Disordered Breathing', 'Glucose Intolerance']}, 'descriptionModule': {'briefSummary': 'Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.\n\nThe objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent residents of Puno, Peru\n\nExclusion Criteria:\n\n* Recent travel to low altitude (\\<3000 m)\n* Oxygen use\n* Pregnancy\n* Morbid obesity (BMI \\> 40 kg/m2)\n* Current smoking\n* Diabetes\n* Other sleep disorders (e.g. circadian rhythm disorder or insomnia)\n* Use of open fires in the home (i.e. for cooking or heat)\n* Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation \\< 85%, Qinghai CMS \\>10 or excessive erythrocytosis as defined by hemoglobin \\>19 g/dL in women or \\>21 g/dL in men.'}, 'identificationModule': {'nctId': 'NCT05462834', 'briefTitle': 'Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing', 'orgStudyIdInfo': {'id': 'IRB00329264'}, 'secondaryIdInfos': [{'id': 'K23HL155730', 'link': 'https://reporter.nih.gov/quickSearch/K23HL155730', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compressed Air then Supplemental Oxygen', 'interventionNames': ['Other: Compressed Air', 'Other: Supplemental Oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Supplemental Oxygen then Compressed Air', 'interventionNames': ['Other: Compressed Air', 'Other: Supplemental Oxygen']}], 'interventions': [{'name': 'Compressed Air', 'type': 'OTHER', 'description': 'Participants will be instructed to use compressed air during sleep as a placebo control.', 'armGroupLabels': ['Compressed Air then Supplemental Oxygen', 'Supplemental Oxygen then Compressed Air']}, {'name': 'Supplemental Oxygen', 'type': 'OTHER', 'description': 'Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.', 'armGroupLabels': ['Compressed Air then Supplemental Oxygen', 'Supplemental Oxygen then Compressed Air']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Luu Pham, MD', 'role': 'CONTACT', 'email': 'lpham1@jhmi.edu', 'phone': '4105502118'}], 'overallOfficials': [{'name': 'Luu Pham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'PRISMA A.B.', 'class': 'UNKNOWN'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}