Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06677151
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in severity of apnea hypopnea index (AHI)', 'timeFrame': 'Baseline (day 0), 30 days', 'description': 'The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['nasopharyngeal'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capacity and willingness to sign consent\n* Patient willingness to commit to and complete study over a 30-day time period\n* Confirmed diagnosis of moderate to severe OSA (AHI \\>= 15)\n* OSA caused by upper airway obstruction\n* CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy\n* Adequate manual dexterity to demonstrate ability to self-insert and remove device\n\nExclusion Criteria:\n\n* Within 3 months of initiating CPAP use, and actively using CPAP\n* Supraglottic airway collapse\n* Distal airway stenosis\n* Tracheobronchomalacia\n* Currently pregnant\n* Active COVID-19 infection\n* Need for anticoagulative therapy\n* Severe nasal allergies\n* Bleeding disorder\n* More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time\n* Restrictive thoracic disorders\n* Silicone, lidocaine, neosynephrine allergy\n* Recurrent epistaxis\n* Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure'}, 'identificationModule': {'nctId': 'NCT06677151', 'briefTitle': 'NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients', 'orgStudyIdInfo': {'id': 'HUM00179497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasopharyngeal airway device', 'description': 'A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.', 'interventionNames': ['Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device']}], 'interventions': [{'name': 'nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device', 'type': 'DEVICE', 'description': "The NPA-OSA is a flexible, medical-grade silicone, tube-like device that is self-inserted into the user's nasopharyngeal airway through one nostril prior to sleep and worn throughout the night to reduce or alleviate snoring and obstructive sleep apnea.", 'armGroupLabels': ['Nasopharyngeal airway device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zahra Nourmohammadi, PhD', 'role': 'CONTACT', 'email': 'znourmoh@med.umich.edu'}, {'name': "Louise M O'Brien, PhD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michigan Medicine', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zahra Nourmohammadi', 'role': 'CONTACT', 'email': 'znourmoh@med.umich.edu', 'phone': '734-936-9816'}, {'name': "Louise O'Brien, PhD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeff Plott, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Zahra Nourmohammadi, PhD', 'role': 'CONTACT', 'email': 'znourmoh@med.umich.edu', 'phone': '734 936-9816'}, {'name': "Louise M O'Brien, PhD", 'role': 'CONTACT', 'email': 'louiseo@med.umich.edu', 'phone': '734 647-9064'}], 'overallOfficials': [{'name': "Louise M O'Brien, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wallace H Coulter Center for Translational Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Sleep Medicine', 'investigatorFullName': "Louise O'Brien", 'investigatorAffiliation': 'University of Michigan'}}}}