Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03428516
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sympathetic tone (MSNA)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'Change from Baseline Sympathetic tone at 1 months'}], 'secondaryOutcomes': [{'measure': '24 hours Systolic Blood pressure (AMBP)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'Change from Baseline in 24 hours ambulatory systolic blood pressure'}, {'measure': 'Systolic Blood pressure (office)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)'}, {'measure': 'Diastolic Blood pressure (office) change after 1 month', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)'}, {'measure': 'Mean Blood pressure (office)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)'}, {'measure': 'Catecholamines (epinephrine)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': '24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (CoulArray® Detector from ESA- Dionex, Chelmsford, USA).'}, {'measure': 'Norepinephrine)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': '24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (CoulArray® Detector from ESA- Dionex, Chelmsford, USA).'}, {'measure': 'Dopamine (Catecholamine)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': '24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (CoulArray® Detector from ESA- Dionex, Chelmsford, USA).'}, {'measure': 'High-frequency component of Heart rate variability', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'We will use these mathematical methods to analyze a signal over time: temporal analysis, Fourier transformation and wavelet transformation.\n\nHigh-frequency (HF) translates fluctuations in parasympathetic activity to cardiac destination, modulated by ventilatory characteristics (frequency, courant volume).'}, {'measure': 'Low frequency component of Heart rate variability', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'We will use these mathematical methods to analyze a signal over time: temporal analysis, Fourier transformation and wavelet transformation.\n\nLow frequency (LF) is classically considered to reflect the activity of the sympathetic system rather than the parasympathetic system.'}, {'measure': '24 hours Diastolic blood pressure change (AMBP)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'ambulatory measurements over 24h'}, {'measure': '24 hours Mean Blood pressure (AMBP)', 'timeFrame': 'Change from baseline after one month of intervention', 'description': 'ambulatory measurements over 24h'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea Syndromes']}, 'referencesModule': {'references': [{'pmid': '27091542', 'type': 'BACKGROUND', 'citation': 'Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.'}, {'pmid': '30948567', 'type': 'DERIVED', 'citation': 'Treptow E, Pepin JL, Bailly S, Levy P, Bosc C, Destors M, Woehrle H, Tamisier R. Reduction in sympathetic tone in patients with obstructive sleep apnoea: is fixed CPAP more effective than APAP? A randomised, parallel trial protocol. BMJ Open. 2019 Apr 4;9(4):e024253. doi: 10.1136/bmjopen-2018-024253.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure', 'detailedDescription': 'Background: Sleep apnea syndrome (SAS) currently affects 10% of general population. It is characterized by the occurrence during the sleep of the upper airways closure which cause repeated asphyxia. It is a public health problem due to its cardiometabolic complications. Indeed, the absence of SAS treatment increases cardiovascular mortality by 12% at 10 years.\n\nThe main physiopathological mechanism is the activation of cardiovascular sympathetic control (the short-term regulation of blood pressure which bring in the sympathetic nervous system) An exposure to intermittent chronic hypoxia (caused by SAS) bring an increased of muscle sympathetic nerve activity (MSNA) contributing to elevated blood pressure Continuous Positive Airway Pressure (CPAP) can partly reduce this risk by decreasing elevation of blood pressure caused by the SAS. It has recently been demonstrated that all CPAP devices are not equivalent. Indeed, the auto-adjusted CPAP treatment induces a reduction in blood pressure lower than the reference treatment fixed CPAP.\n\nTo this extent it is interesting to conduct a new randomized trial comparing these two treatments with vascular sympathetic tone. This will be assessed by peroneal microneurography recording.\n\nObjective: Compare Muscle Sympathetic Neural Activity (MSNA) by microneurography after one month of fixed versus auto-adjusted CPAP treatment in OSA patients naive from pressure therapy Methods: Prospective study, single-site, randomized, double-blind, parallel, one month controlled trial. After the diagnosis of sleep apnea, patients will be randomized for one month treatment with fixed ou auto-adjusting CPAP. Measurements of MSNA, heart rate variability and catecholamines will be held before and after treatment.\n\nAn interim analysis will be performed after the inclusion of 24 patients based on group sequential design.\n\nAssuming an α error of 5%, a statistical power of 80%, and a unilateral situation : 34 patients per arm will be needed to be enrolled in the study. The enrollment target for the study will be reviewed and may be refined following the study interim analysis and taking account 20% of study drop-out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with OSA (AHI ≥20 / h)\n* patient with daytime sleepiness\n* naive of any pressure treatment of OSA\n* patient able to provide written informed consent\n* not a vulnerable person or legally protected adult.\n\nExclusion Criteria:\n\n* pregnancy\n* Person deprived of liberty or subject to a legal protection measure.\n* Patient with serious heart failure (According to investigator judgment)\n* patient with central sleep apnea index above 20% of AHI\n* Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).'}, 'identificationModule': {'nctId': 'NCT03428516', 'acronym': 'APAP-CPAP', 'briefTitle': 'Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?', 'orgStudyIdInfo': {'id': '2017-A02937-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed CPAP', 'description': 'CPAP always deliver air with the same pressure', 'interventionNames': ['Device: Fixed CPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auto-adjusting CPAP', 'description': 'Auto-CPAP changes the pressure delivered depending on events detected at any time (apnea, hypopnea …) and applies the lowest pressure required to eliminate events.', 'interventionNames': ['Device: Auto-adjusting CPAP']}], 'interventions': [{'name': 'Fixed CPAP', 'type': 'DEVICE', 'description': 'CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep', 'armGroupLabels': ['Fixed CPAP']}, {'name': 'Auto-adjusting CPAP', 'type': 'DEVICE', 'description': 'Auto-adjusting CPAP is a device that applies auto-adjusting continous positive pressure to the airways in order to keep them opened during sleep', 'armGroupLabels': ['Auto-adjusting CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Renaud Tamisier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Alps'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}, {'name': 'ResMed', 'class': 'INDUSTRY'}, {'name': 'Agir pour les maladies chroniques', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}