NCT06748703Recruiting
Optic Nerve Injury in Obstructive Sleep Apnea Patients
Optic Nerve Injury and the Effect of CPAP Treatment in Obstructive Sleep Apnea Patients
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Nanjing Medical University
- Diseases
- Stroke
- NCT number
- NCT06748703
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of severe stroke or cerebral hemorrhage, or presence of neurological or psychiatric conditions that could affect study results.
- Presence of active malignancies or other severe underlying diseases, such as severe liver or kidney dysfunction. Diagnosed with diabetes or other significant vascular diseases.
- Presence of severe chronic obstructive pulmonary disease (COPD), severe asthma, severe pulmonary hypertension, or heart failure caused by any condition.
- Pregnancy or having other conditions that make participation in this study unsuitable.
- Extremely debilitated patients or those with severe underlying conditions.
Who the study is looking for
- Patients aged between 18 and 80 years.
- Diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)(apnea-hypopnea index≥5/h).
- First-time diagnosis, with no previous surgical interventions or CPAP treatment for OSA.
- Ability and willingness to provide informed consent for participation in the study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.