Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 2:03 AM
Study NCT ID:
NCT05252156
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2022-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
eXciteOSA for Treatment of Moderate 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2022-02-12', 'studyFirstSubmitQcDate': '2022-02-12', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy', 'timeFrame': 'Six weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged \\>=18 years;\n* Diagnosed with moderate OSA;\n* Smartphone or tablet capable of running the eXciteOSA app;\n* Fluent in written and spoken English.\n\nExclusion Criteria:\n\n* BMI \\>=35 kg/m2;\n* Implanted medical device;\n* Dental braces and/or intraoral metal jewelry;\n* Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;\n* Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;\n* Tonsillar hypertrophy (tonsil size grade 3 or greater);\n* Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;\n* Prior oropharyngeal surgery for sleep-disordered breathing;\n* At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;\n* Use of any overnight therapy that cannot be withdrawn during study enrollment;\n* Diagnosed with any sleep disorder other than OSA;\n* Chronic use of central nervous system depressants;\n* Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);\n* Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;\n* Considered by the PI to be at risk of an AE resulting from hypersomnolence;\n* Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;\n* Current or planned pregnancy;\n* Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;\n* Clinically-significant burden of comorbidities (including history of myocardial infarction, cardiac arrhythmia, heart failure, history of stroke, or transient ischemic attack), and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);\n* Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor)."}, 'identificationModule': {'nctId': 'NCT05252156', 'acronym': 'ELMO', 'briefTitle': 'eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Signifier Medical Technologies'}, 'officialTitle': 'An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial', 'orgStudyIdInfo': {'id': 'SMT_EOSA_SZT_0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapy Dose-A', 'description': 'Neuromuscular electrical stimulation; two 20-minute sessions per day.', 'interventionNames': ['Device: eXciteOSA']}, {'type': 'EXPERIMENTAL', 'label': 'Therapy Dose-B', 'description': 'Neuromuscular electrical stimulation; one 30-minute session per day.', 'interventionNames': ['Device: eXciteOSA']}, {'type': 'NO_INTERVENTION', 'label': 'No Therapy', 'description': 'Under the care of the referring physician, with no therapy applied'}], 'interventions': [{'name': 'eXciteOSA', 'type': 'DEVICE', 'description': 'eXciteOSA', 'armGroupLabels': ['Therapy Dose-A', 'Therapy Dose-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Delta Waves', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33971', 'city': 'Lehigh Acres', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Lung & Sleep Associates', 'geoPoint': {'lat': 26.62535, 'lon': -81.6248}}, {'zip': '21286', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pulmonary and Critical Care Associates of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63143', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clayton Sleep Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Yasser Zayni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'yasser.z@signifiermedical.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Signifier Medical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}