Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT01860560
Status:
WITHDRAWN
Last Update Posted:
2023-05-03
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Inferiority Trial of Acute HFT Versus nCPAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'this was an error. Study never initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AHI Change (Therapy v Baseline)', 'timeFrame': 'Acute - single night therapy exposure', 'description': 'Evaluate the change in AHI from baseline for HFT v CPAP therapy'}], 'secondaryOutcomes': [{'measure': 'Pulse Oxygen Saturation', 'timeFrame': 'Acute single night therapy exposure', 'description': 'Evaluate the mean, absolute minimum, absolute event-related nadir and mean nadir of pulse oxygen saturation during therapeutic polysomnography of HFT v CPAP'}, {'measure': 'Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)', 'timeFrame': 'Acute single night therapy exposure', 'description': 'Evaluate changes in sleep architecture on HFT and CPAP therapy as compared to baseline diagnostic polysomnography. Specifically, evaluate any difference between the therapies on %Wake Time (of SPT), % time in stages N1, N2, N3, REM (of TST), Minutes of Wake After Sleep onset, Sleep latency and REM Latency. Any difference in overall non-respiratory arousal index will be assessed.'}, {'measure': 'Respiratory Event Related Arousals', 'timeFrame': 'Acute single night therapy exposure', 'description': 'Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.'}, {'measure': 'Respiratory Disturbance Index (RDI)', 'timeFrame': 'Acute single night therapy exposure', 'description': 'Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSA', 'Obstructive Sleep Apnea', 'High Flow Therapy', 'CPAP', 'HFT', 'Continuous Positive Airway Pressure', 'Mild OSA', 'Moderate OSA'], 'conditions': ['Mild-Moderate Obstructive Sleep Disordered Breathing']}, 'descriptionModule': {'briefSummary': 'Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).', 'detailedDescription': 'Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to receive HFT or CPAP in the laboratory, undergo a washout period, and return for the alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to CPAP in controlling Apnea/Hypopnea events in this subject set during this study.\n\nPrimary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to baseline diagnostic polysomnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography\n* Ability to read and understand English Language\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Unstable medical illness within the last month (30 days)\n* Acute / recent upper airway infection\n* Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)\n* Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities\n* Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow\n* Patients using opioids or amphetamines will be excluded from the study.\n* Enhanced oxygen requirement (i.e., FiO2\\>0.21)\n* Patients requiring Bi-Level therapy upon CPAP titration attempt\n* Surgery since the diagnostic PSG\n* Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)\n* Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)\n* Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)\n* Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)\n* Unsuitable for inclusion in the opinion of the investigators'}, 'identificationModule': {'nctId': 'NCT01860560', 'briefTitle': 'Non-Inferiority Trial of Acute HFT Versus nCPAP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vapotherm, Inc.'}, 'officialTitle': 'Effect of High Flow Nasal Cannula (Flowrest®) on Mild-Moderate Sleep Disordered Breathing: A Non-Inferiority Study Versus Nasal Continuous Positive Airway Pressure (CPAP) Therapy', 'orgStudyIdInfo': {'id': 'RP-HFR2013001Reg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP First / HFT Second', 'description': 'Subjects to receive both therapies, order-randomized to receive Continuous Positive Airway Pressure (CPAP) therapy study first, followed by a washout period, and a follow-on High-Flow Therapy (HFT) therapy study', 'interventionNames': ['Device: High-Flow Therapy', 'Device: Continuous Positive Airway Pressure']}, {'type': 'EXPERIMENTAL', 'label': 'HFT First / CPAP Second', 'description': 'Subjects to receive both therapies, order-randomized to receive High-Flow Therapy (HFT) therapy study first, followed by a washout period, and a follow-on Continuous Positive Airway Pressure (CPAP) therapy study.', 'interventionNames': ['Device: High-Flow Therapy', 'Device: Continuous Positive Airway Pressure']}], 'interventions': [{'name': 'High-Flow Therapy', 'type': 'DEVICE', 'otherNames': ['Vapotherm Flowrest High Flow Therapy'], 'description': 'Blower-based High Flow Therapy delivered by nasal cannula', 'armGroupLabels': ['CPAP First / HFT Second', 'HFT First / CPAP Second']}, {'name': 'Continuous Positive Airway Pressure', 'type': 'DEVICE', 'otherNames': ['Respironics Synchrony Lab'], 'description': 'CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.', 'armGroupLabels': ['CPAP First / HFT Second', 'HFT First / CPAP Second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sleep Disorders Centers of the Mid-Atlantic', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}], 'overallOfficials': [{'name': 'George Dungan, MPhil Med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vapotherm, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vapotherm, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}