Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-01 @ 2:58 PM
Study NCT ID:
NCT06748703
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Injury in Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D018917', 'term': 'Optic Neuropathy, Ischemic'}], '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': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve and macular blood flow', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Changes in optic nerve and macular blood flow in patients with OSA of varying severity were measured using blood flow optical coherence tomography (blood flow OCT).'}, {'measure': 'Apnea Hypopnea Index (AHI)', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Number of apneas and hypoventilations per hour of sleep'}, {'measure': 'Hypoxic Burden（HB）', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The sum of the area between the SpO2 trace and the desaturation baseline associated with all apnoea and hypopnoea events is divided by the total time of sleep.'}, {'measure': 'Ventilatory burden', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The average ventilatory burden per event was defined as the multiplication of the average ventilation during the respiratory event and average duration of respiratory events. The total ventilatory burden for each participant was defined as the multiplication of respiratory event rate and average ventilatory area per event.'}, {'measure': 'Blood pressure variability', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The main studies were on ultrashort-term variability (blood pressure variability between each heart beat) and short-term variability (blood pressure variability over a 24-hour period).'}, {'measure': 'Heart rate variability', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Heart rate variability (HRV) is the variation of differences between consecutive cardiac cycles. For example, the standard deviation of NN intervals in 24 h (SDNN), the standard deviation of the mean of NN intervals per 5 min (SDANN), and the SDNN during wakefulness and sleep.'}, {'measure': 'Pulse Wave Amplitude Drops Index', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The number of decreases (\\>30%) in pulse wave amplitude per hour detected by pulse oximetry based on photoplethysmographic volumetric tracing (PPG) signals during sleep.'}], 'secondaryOutcomes': [{'measure': 'Time below 90% Saturation', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Percentage of total time with oxygen saturation below 90% of total monitoring time.'}, {'measure': 'Lowest SpO2 at night', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The lowest SpO2 value recorded during the nightly test.'}, {'measure': 'Mean SpO2', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Mean SpO2 values during nighttime monitoring.'}, {'measure': 'Oxygen Desaturation Index', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The number of oxygen desaturation events per hour of sleep.The desaturation thresholds of 3% (ODI3) or 4% (ODI4) are commonly chosen in the analysis of OSA.'}, {'measure': 'Vision', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': "The patient's naked eye visual acuity in the right and left eyes was checked using a visual acuity chart."}, {'measure': 'Diopter', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Qualitative and quantitative analysis of the refractive status of the eye under test using computerized optometry.'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'Measurement of intraocular pressure (IOP) in the eye under test using a non-contact tonometer.'}, {'measure': 'Field of view', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'An automated visual field meter was used to detect the total loss of the visual field and the extent and depth of limiting defects in the tested eye.'}, {'measure': 'Axon of the eye', 'timeFrame': 'Baseline and 3 months of CPAP therapy', 'description': 'The IOLMaster was utilized to measure the eye axis of the tested eye.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Nonarteritic Ischemic Optic Neuropathy', 'CPAP treatment'], 'conditions': ['Obstructive Sleep Apnea (OSA)', 'Ischemic Optic Neuropathy/Optic Nerve Stroke']}, 'descriptionModule': {'briefSummary': 'Ischemic optic neuropathy (ION) is damage to the optic nerve caused by ischemia and hypoxia of the optic nerve due to an impairment of the blood supply to the optic nerve from the arteries. Obstructive Sleep Apnea Hypoventilation Syndrome (OSAHS) is a sleep-breathing disorder characterized by recurrent upper airway obstruction and apnea during sleep, leading to recurrent intermittent hypoxemia with fragmented sleep and daytime sleepiness. Due to the lack of accurate methods to evaluate blood flow, the correlation between the two is unclear and uncertain. The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University and categorize them into mild, moderate, and severe OSA groups according to their apnea-hypopnea index (AHI). Participants will undergo a baseline evaluation, including polysomnography (PSG) and ophthalmologic examinations such as optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure, and visual fields. Eligible patients will be treated with CPAP for 3 months, after which their PSG and ophthalmologic examination-related results will be re-evaluated to assess treatment efficacy.', 'detailedDescription': 'Ischemic optic neuropathy (ION) is damage to the optic nerve caused by ischemia and hypoxia in the optic nerve due to impairment of the blood supply of the arteries supplying the optic nerve. ION is an important blinding eye disease. It has been found that patients with OSAHS are often misdiagnosed as having normotensive glaucoma due to chronic hypoxia resulting in optic nerve ischemia and hypoxia, leading to the development of ION. However, the correlation between the two has been poorly studied and is uncertain due to the lack of accurate methods to evaluate blood flow.\n\nThe study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University between the ages of 18-80 years. Participants will be diagnosed with OSA according to established guidelines and must be first-time visitors with no prior history of OSA surgery or CPAP treatment. Patients with severe cerebrovascular disease, psychiatric disorders, diagnosed diabetes mellitus with severe vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.\n\nAll participants will undergo a polysomnography (PSG) to determine the Apnea Hypopnea Index (AHI) and will be categorized into mild, moderate, or severe OSA groups. Ophthalmologic-related examinations will be performed to measure ocular parameters such as optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure (IOP), visual fields, and IOLMaster measurements of the eye axis.\n\nEligible patients will receive CPAP treatment for 3 months. After 3 months of CPAP treatment, participants will undergo another PSG examination with ophthalmologic correlation to re-evaluate sleep parameters and ocular parameters.\n\nThe collected data will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, minimum SPO2, hypoxic load, respiratory load, blood pressure variability, heart rate variability, pulse wave amplitude decline index, ESS drowsiness score, and the following ophthalmologic parameters: optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure, visual field, and eye axis as measured by IOLMaster. Paired t-tests will be performed to analyze the changes in the above indexes before and after CPAP treatment; ANOVA with repeated measurements will be performed to analyze the long-term changes in the above indexes.\n\nThe aim of this study is to analyze the relationship between sleep apnea severity hypoxia indexes and ION in OSAHS patients. To analyze the improvement of ischemic optic neuropathy (ION) after 3 months of CPAP treatment and to establish a long-term cohort to observe the occurrence of ION in patients with OSA of different severities, as well as the improvement of ION with long-term CPAP treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged between 18 and 80 years.\n2. Diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)(apnea-hypopnea index≥5/h).\n3. First-time diagnosis, with no previous surgical interventions or CPAP treatment for OSA.\n4. Ability and willingness to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. History of severe stroke or cerebral hemorrhage, or presence of neurological or psychiatric conditions that could affect study results.\n2. Presence of active malignancies or other severe underlying diseases, such as severe liver or kidney dysfunction. Diagnosed with diabetes or other significant vascular diseases.\n3. Presence of severe chronic obstructive pulmonary disease (COPD), severe asthma, severe pulmonary hypertension, or heart failure caused by any condition.\n4. Pregnancy or having other conditions that make participation in this study unsuitable.\n5. Extremely debilitated patients or those with severe underlying conditions.'}, 'identificationModule': {'nctId': 'NCT06748703', 'briefTitle': 'Optic Nerve Injury in Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Optic Nerve Injury and the Effect of CPAP Treatment in Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': '2024-SR-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP Treatment Group', 'description': 'Patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) who are eligible for CPAP therapy.', 'interventionNames': ['Device: CPAP Treatment']}], 'interventions': [{'name': 'CPAP Treatment', 'type': 'DEVICE', 'description': "CPAP therapy will be administered to patients for 3 months. The CPAP device will be set to deliver a continuous flow of air at a prescribed pressure to keep the patient's airway open during sleep.", 'armGroupLabels': ['CPAP Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Ding, doctor', 'role': 'CONTACT', 'email': 'dr.ningding@live.cn', 'phone': '86-25-68136723'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Ning Ding,MD,PhD', 'role': 'CONTACT', 'email': 'dr.ningding@live.cn', 'phone': '86-25-68136723'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be shared. The informed consent will be ansigned before enrolled in the study and ensured to keep personal information confidential.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ning Ding', 'investigatorAffiliation': 'Nanjing Medical University'}}}}