Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06748703

Optic Nerve Injury in Obstructive Sleep Apnea Patients

Led by Nanjing Medical University · Updated on 2025-06-27

80

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optic Nerve Injury in Obstructive Sleep Apnea Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 80 years
  • Diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) with apnea-hypopnea index of 5 or more per hour
  • First-time diagnosis with no prior surgery or CPAP treatment for OSA
  • Able and willing to provide informed consent for study participation
Not Eligible

You will not qualify if you...

  • History of severe stroke, cerebral hemorrhage, or neurological or psychiatric conditions affecting study results
  • Active cancer or severe diseases such as severe liver or kidney problems, diagnosed diabetes with vascular complications, or major vascular diseases
  • Severe chronic lung diseases including COPD, asthma, severe pulmonary hypertension, or heart failure
  • Pregnancy or other conditions making study participation unsuitable
  • Extremely debilitated patients or those with severe underlying conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

N

Ning Ding,MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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