Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-10 @ 7:18 PM
Study NCT ID:
NCT03854058
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2019-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D017286', 'term': 'Polysomnography'}, {'id': 'D019296', 'term': 'Capnography'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carbon dioxide rebreathing test', 'timeFrame': '1 day', 'description': 'minute volumen (L/min)'}, {'measure': 'transdiaphragmatic pressure (non-volitional)', 'timeFrame': '1 day', 'description': 'difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves'}, {'measure': 'peripheral nervous system (non-volitional)', 'timeFrame': '1 day', 'description': 'electroneurography after posterior magnetic stimulation of the phrenic nerves'}, {'measure': 'diaphragmal ultrasound - excursion (non-volitional)', 'timeFrame': '1 day', 'description': 'excursion of the diaphragm'}, {'measure': 'diaphragmal ultrasound - thickness (non-volitional)', 'timeFrame': '1 day', 'description': 'thickness of the diaphragm'}, {'measure': 'P0.1 (volitional)', 'timeFrame': '1 day', 'description': 'mouth occlusion pressure (kPa)'}, {'measure': 'PImax (volitional)', 'timeFrame': '1 day', 'description': 'maximal inspiratory mouth pressure (kPa)'}], 'secondaryOutcomes': [{'measure': 'Comparison of PImax and transdiaphragmatic pressure', 'timeFrame': '1 day', 'description': 'Correlation between PImax and transdiaphragmatic pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity Hypoventilation Syndrome']}, 'descriptionModule': {'briefSummary': 'Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to\n\n* identify potential determinants for the development of obesity hypoventilation\n* to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with OHS or OHS-risk', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with BMI \\> 30 and obesity-associated hypoventilation stages I - IV\n* patients with BMI \\> 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)\n* age:18-80 years\n* capacity to consent\n\nExclusion Criteria:\n\n* any other disease, that causes ventilatory insufficiency\n* pacemaker, defibrillators or device for deep brain or vagus nerve stimulation\n* esophagitis, Barrett-esophagus, esophageal cancer\n* acute gastritis and ulcera ventriculi\n* epilepsy\n* any medical, psychological or other condition impairing the patient's ability to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03854058', 'briefTitle': 'Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wissenschaftliches Institut Bethanien e.V'}, 'officialTitle': 'Multimodal Measurement of Respiratory Muscle Strength by Using Volitional and Non-volitional Tests in Patients With Obesity Hypoventilation Syndrome (OHS), Obesity-associated Hypoventilation and OHS-Risk-Patients to Evaluate Pathophysiological Determinants and Predictors for the Presence of a Sleep-related Hypoventilation Requiring Treatment in Obese Patients', 'orgStudyIdInfo': {'id': 'WI_18-340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OHS or elevated OHS-risk (stages 0-IV)', 'description': 'stage 0: OHS-risk (OSA / no hypercapnia)\n\nstage I: obesity associated hypoventilation (intermittent hypercapnia during sleep, arterial carbon dioxide partial pressure (PaCO2) or transcutaneous carbon dioxide partial pressure (PtcCO2) morning \\~ evening), bicarbonate \\< 27 mmol/L awake)\n\nstage II: obesity associated hypoventilation (intermittent hypercapnia during sleep, PaCO2 or PtcCO2 morning \\> evening, bicarbonate ≥ 27 mmol/L awake)\n\nstage III: OHS (hypercapnia, carbon dioxide partial pressure (PCO2) \\> 45 mmHg awake)\n\nstage IV: OHS with end organ damage (hypercapnia , PCO2 \\> 45 mmHg awake, cardiometabolic comorbidities)\n\ndiagnostic tests: magnetic phrenic nerve stimulation, diaphragmatic ultrasound', 'interventionNames': ['Diagnostic Test: magnetic phrenic nerve stimulation']}], 'interventions': [{'name': 'magnetic phrenic nerve stimulation', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['diaphragmatic ultrasound', 'spirometry', 'Sleep-studies', 'capnography'], 'description': 'cervical and cortical stimulation of N. Vagus', 'armGroupLabels': ['OHS or elevated OHS-risk (stages 0-IV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42699', 'city': 'Solingen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anja Pietzke-Calcagnile', 'role': 'CONTACT', 'email': 'institut@klinik-bethanien.de', 'phone': '0212636663'}, {'name': 'Marcel Treml', 'role': 'CONTACT', 'email': 'institut@klinik-bethanien.de', 'phone': '0212636661'}], 'facility': 'Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}], 'centralContacts': [{'name': 'Anja Pietzke-Calcagnile, Dr.', 'role': 'CONTACT', 'email': 'anja.pietzke-calcagnile@klinik-bethanien.de', 'phone': '+49212636663'}], 'overallOfficials': [{'name': 'Winfried J Randerath, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wissenschaftliches Institut Bethanien e.V'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wissenschaftliches Institut Bethanien e.V', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}