Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-21 @ 3:37 PM
Study NCT ID:
NCT02398032
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP in SAHS Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.', 'timeFrame': '3 months', 'description': "To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the withdrawal response (decrease in ventilation caused by two breaths of 100% oxygen, %ΔV'I) and in the ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia (ΔV'I/arterial oxygen saturation (SaO2)/body surface area (BSA)\\] and Δ occlusion pressure at 0.1 s (P0.1)/arterial oxygen saturation (SaO2), respectively)."}], 'secondaryOutcomes': [{'measure': 'CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index', 'timeFrame': '3 months', 'description': 'To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the sniff diaphragmatic tension-time index (TTdi)'}, {'measure': 'CPAP effect on blood pressure', 'timeFrame': '3 months', 'description': 'To compare the effect of three months of CPAP therapy on the blood pressure in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension'}, {'measure': 'CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1', 'timeFrame': '3 months', 'description': 'To compare the effect of three months of CPAP therapy versus sham CPAP on the serum levels of endothelin-1 and VCAM-1 in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension'}, {'measure': 'CPAP effect on the night-morning change in the rest metabolic rate', 'timeFrame': '3 months', 'description': 'To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the rest metabolic rate (carbon dioxide production/oxygen uptake ratio, RER)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'hypertension', 'mechanosensitivity', 'chemosensitivity', 'adhesion factors'], 'conditions': ['Sleep Apnea Syndromes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '29146604', 'type': 'DERIVED', 'citation': 'Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Gonzalez-Villalba MJ, Fernandez-Navarro I, Sanchez B, Garcia-Sanchez A, Zamarron E, Garcia-Rio F. The effect of treatment for sleep apnoea on determinants of blood pressure control. Eur Respir J. 2017 Nov 16;50(5):1701261. doi: 10.1183/13993003.01261-2017. Print 2017 Nov.'}]}, 'descriptionModule': {'briefSummary': 'Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters.\n\nDesign: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area. Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with SAHS without previous treatment. At least 30 patients are needed.\n\nInterventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial.\n\nMeasurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) \\> 10 h-1\n* No previous treatment for SAHS or hypertension\n* Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure \\<135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).\n\nExclusion Criteria:\n\n* Severe hypertension (\\> 180/120 mmHg).\n* Previous diagnosis of secondary hypertension.\n* Myocardial infarction or stroke in the last three months.\n* Severe diurnal sleepiness (Epworth score \\> 15)\n* Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.\n* Previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction.\n* Morbid obesity (BMI \\> 40 Kg/m2)\n* Respiratory infection in the last two months.\n* Treatment with theophylline or systemic corticosteroids in the last two years.\n* Excessive alcohol intake (\\>40 g/day)\n* Absence of social or familiar support.'}, 'identificationModule': {'nctId': 'NCT02398032', 'acronym': 'SAHS2-3', 'briefTitle': 'CPAP in SAHS Patients With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension', 'orgStudyIdInfo': {'id': '99/0252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP nasal', 'description': 'Nasal continuous positive airway pressure, during the night', 'interventionNames': ['Device: CPAP nasal']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham CPAP nasal', 'description': 'Nasal sham continuous positive airway pressure, during the night', 'interventionNames': ['Device: sham CPAP nasal']}], 'interventions': [{'name': 'CPAP nasal', 'type': 'DEVICE', 'otherNames': ['Nocturnal support with continuous positive airway pressure'], 'description': 'During the night', 'armGroupLabels': ['CPAP nasal']}, {'name': 'sham CPAP nasal', 'type': 'DEVICE', 'otherNames': ['sham CPAP'], 'description': 'During the night', 'armGroupLabels': ['sham CPAP nasal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Francisco Garcia-Rio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz, IdiPAZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francisco Garcia-Rio', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}