Optic Nerve Injury in Obstructive Sleep Apnea Patients

NCT ID: NCT06748703

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed Description

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.

The 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.

All 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.

Eligible 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.

The 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.

The 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.

Conditions

Obstructive Sleep Apnea (OSA); Ischemic Optic Neuropathy/Optic Nerve Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP Treatment Group

Patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) who are eligible for CPAP therapy.

Group Type: EXPERIMENTAL

CPAP Treatment

Intervention Type: DEVICE

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.

Interventions

CPAP Treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged between 18 and 80 years.

2. Diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)(apnea-hypopnea index≥5/h).

3. First-time diagnosis, with no previous surgical interventions or CPAP treatment for OSA.

4. Ability and willingness to provide informed consent for participation in the study.

Exclusion Criteria

1. History of severe stroke or cerebral hemorrhage, or presence of neurological or psychiatric conditions that could affect study results.

2. Presence of active malignancies or other severe underlying diseases, such as severe liver or kidney dysfunction. Diagnosed with diabetes or other significant vascular diseases.

3. Presence of severe chronic obstructive pulmonary disease (COPD), severe asthma, severe pulmonary hypertension, or heart failure caused by any condition.

4. Pregnancy or having other conditions that make participation in this study unsuitable.

5. Extremely debilitated patients or those with severe underlying conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ning Ding

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Ding,MD,PhD

Role: CONTACT

dr.ningding@live.cn

86-25-68136723

Facility Contacts

Ning Ding, doctor

Role: primary

dr.ningding@live.cn

86-25-68136723

Other Identifiers

2024-SR-204

Identifier Type: -

Identifier Source: org_study_id