Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 12:49 PM
Study NCT ID:
NCT07039500
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001308', 'term': 'Auditory Perceptual Disorders'}], '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'}, {'id': 'D001304', 'term': 'Auditory Diseases, Central'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of Mismatch Negativity (MMN)', 'timeFrame': 'Day 1', 'description': 'EEG-derived MMN amplitude (microvolts, μV) during oddball task. Lower values indicate impaired automatic sound change detection.'}, {'measure': 'Latency of Mismatch Negativity (MMN)', 'timeFrame': 'Day 1', 'description': 'EEG-derived MMN latency (milliseconds, ms) during oddball task. Longer values indicate slower automatic processing.'}], 'secondaryOutcomes': [{'measure': 'Reaction Time in Active Auditory Oddball Task', 'timeFrame': 'Day 1', 'description': 'Time taken to press button after deviant sound onset (milliseconds). Higher values indicate slower processing speed.'}, {'measure': 'Accuracy in Active Auditory Oddball Task', 'timeFrame': 'Day 1', 'description': 'Percentage of correct button presses to deviant sounds (%). Lower values indicate worse performance.'}, {'measure': 'Inter-Trial Phase Coherence (ITPC) in Theta/Alpha/Beta Bands', 'timeFrame': 'Day 1', 'description': 'EEG oscillatory synchronization (range 0-1; 0=no phase consistency). Lower values indicate neural desynchronization during auditory processing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Auditory Cognition', 'Electroencephalography (EEG)', 'Oddball Paradigm'], 'conditions': ['Obstructive Sleep Apnea', 'Auditory Processing Disorder']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn how severe obstructive sleep apnea-hypopnea syndrome (OSAHS) affects the brain's ability to process sounds and attention in adults aged 20-60 years. The main questions it aims to answer are:\n\n1. Does severe OSAHS change how the brain automatically detects sound changes during wakefulness?\n2. Does severe OSAHS reduce people's ability to pay attention to important sounds when awake?\n3. Can brainwave tests (Electroencephalogram, EEG) detect early signs of hearing-related cognitive problems in OSAHS patients before symptoms appear?\n\nResearchers will compare two groups:\n\n* 50 adults with severe OSAHS (diagnosed by sleep tests)\n* 50 healthy adults matched by age and gender\n\nParticipants will:\n\n* Complete hearing tests (MoCA)\n* Undergo a 1-night sleep test (PSG)\n* Wear an EEG cap for 1.5-2 hours while listening to sounds in a quiet room:\n\n * Passive task: Relax (no response needed)\n * Active task: Press a button when hearing rare sounds\n* Receive ¥75/hour compensation for their time"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two distinct populations:\n\n1. Severe OSAHS Patients:\n\n * Recruited from otolaryngology clinics at Peking University First Hospital\n * Diagnosed via in-lab PSG (AHI\\>30)\n2. Healthy Controls:\n\n * Community volunteers from Beijing area\n * Age/sex-matched to OSAHS group', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll Participants:\n\n* Aged 20-60 years\n* Normal hearing (PTA ≤25 dB HL at 0.5,1,2,4 kHz; Type A tympanogram)\n* MoCA score ≥26\n* Willing to complete EEG testing\n\nOSAHS Group Additional:\n\n\\- PSG-confirmed severe OSAHS (AHI \\>30 events/hour)\n\nControl Group Additional:\n\n* Self-reported absence of snoring/sleep disorders\n* No prior OSAHS diagnosis\n\nExclusion Criteria:\n\nAll Participants:\n\n* History of:\n\n * Schizophrenia, epilepsy, Parkinson's, TBI, or language disorders\n * Middle/inner ear diseases (otitis media, acoustic neuroma, etc.)\n * Cognitive impairment or depression/anxiety disorders\n* Chronic steroid use\n* Systemic inflammatory diseases or malignancies\n* Pregnancy or suspected pregnancy (self-reported)"}, 'identificationModule': {'nctId': 'NCT07039500', 'briefTitle': 'Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing', 'orgStudyIdInfo': {'id': 'PekingUFH-2024RES651-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe OSAHS Group', 'description': 'Adults aged 20-60 years with severe obstructive sleep apnea-hypopnea syndrome (AHI\\>30 events/hour) confirmed by polysomnography (PSG). Participants undergo PSG, hearing tests (pure-tone audiometry, tympanometry), Montreal Cognitive Assessment (MoCA), and EEG recording during active/passive auditory oddball tasks measuring MMN, P300, and behavioral responses.'}, {'label': 'Healthy Control Group', 'description': 'Age/sex-matched healthy adults (20-60 years) with self-reported absence of snoring/sleep disorders. Participants complete hearing tests (pure-tone audiometry, tympanometry), Montreal Cognitive Assessment (MoCA), and EEG recording during identical auditory oddball tasks as the OSAHS group.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caifeng Xia, M.D.', 'role': 'CONTACT', 'email': 'xiacf@pku.edu.cn', 'phone': '+8618811173785'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Caifeng Xia, M.D.', 'role': 'CONTACT', 'email': 'xiacf@pku.edu.cn', 'phone': '+8618811173785'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}