Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT05881512
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2023-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
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': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-25', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Overnight (day 1)', 'description': 'Subjective Questionnaire'}], 'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index', 'timeFrame': 'Overnight (day 1)', 'description': 'Episodes of apnea and/or hypopnea scored during the course of sleep study'}], 'secondaryOutcomes': [{'measure': 'Arterial Oxygen Saturation (SaO2)', 'timeFrame': 'Overnight (day 1)', 'description': 'SaO2 levels during the course of sleep study compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'OSA']}, 'descriptionModule': {'briefSummary': 'Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 years or older\n* In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA\n* In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, \\<25% of the respiratory events on the diagnostic PSG can be attributed to central apneas\n* BMI less than or equal to 32\n\nExclusion Criteria:\n\n* No or mild OSA (AHI \\<15/h) or very severe OSA (AHI \\>50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.\n* Patients who are cachectic (BMI \\<18.5 kg/m2) or obese (BMI \\>32 kg/m2).\n* Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.\n* Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.'}, 'identificationModule': {'nctId': 'NCT05881512', 'briefTitle': 'Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Somnial Inc'}, 'officialTitle': 'Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'SOMN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TUAS', 'description': 'Transcutaneous upper airway stimulation', 'interventionNames': ['Device: Transcutaneous Upper Airway Stimulation Device']}], 'interventions': [{'name': 'Transcutaneous Upper Airway Stimulation Device', 'type': 'DEVICE', 'otherNames': ['TUAS'], 'description': 'Multiple frequency stimulation of the hypoglossal nerve', 'armGroupLabels': ['TUAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'United Diagnostics', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}], 'overallOfficials': [{'name': 'Lee Shangold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ENT & Allergy Associates, LLP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Somnial Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}