Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07243405
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurostimulation for Sleep Disordered Breathing (SDB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, multicenter, single arm, feasibility clinical study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint - assessment of procedure or device related adverse events', 'timeFrame': 'enrollment to 12 months post-implant', 'description': 'Incidence of adverse events (AEs) related to the Lunair system or procedure'}], 'secondaryOutcomes': [{'measure': 'Improvement in sleep disordered breathing per sleep study', 'timeFrame': 'six month, 12 month and 24 month post implant', 'description': 'Improvement in sleep disordered breathing at 6,12 and 24 months post implant during an attended sleep study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disordered Breathing (SDB)', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered Breathing treatments\n* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG\n\nExclusion Criteria:\n\n* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n* Any reason for which, in the judgement of the investigator, the subject is considered to be a poor study candidate\n* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n* Subject has a need for chronic supplemental oxygen therapy for any reason\n* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness\n* Subject has severe chronic kidney disease\n* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study\n* Subject conducts work or regular activities requiring vigilance\n* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study\n* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices\n* Subject has an active systemic infection at the time of implant\n* Subject has clinical evidence of immunodeficiency\n* Any condition likely to require future MRI or diathermy\n* Subject is pregnant\n* Subject has severe nasal obstruction that could restrict airflow\n* Subject has any trauma to the upper airway\n* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat'}, 'identificationModule': {'nctId': 'NCT07243405', 'acronym': 'ECLIPSE 2', 'briefTitle': 'Neurostimulation for Sleep Disordered Breathing (SDB)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lunair Medical'}, 'officialTitle': 'The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing', 'orgStudyIdInfo': {'id': '10138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alpha Lunair System implanted subjects', 'interventionNames': ['Device: Neuro stimulator implant']}], 'interventions': [{'name': 'Neuro stimulator implant', 'type': 'DEVICE', 'description': 'Neuro stimulator for treating sleep disordered breathing', 'armGroupLabels': ['Alpha Lunair System implanted subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'status': 'RECRUITING', 'country': 'Panama', 'contacts': [{'name': 'Kris VP, Clinical Operations', 'role': 'CONTACT', 'email': 'kriss@lunairmedical.com', 'phone': '1-866-675-4430'}], 'facility': 'Hospital Paitilla', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Kris VP, Clinical Operations', 'role': 'CONTACT', 'email': 'kriss@lunairmedical.com', 'phone': '1-866-675-4430'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lunair Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}