Optic nerve blood flow and injury in people with obstructive sleep apnea

Optic Nerve Injury and the Effect of CPAP Treatment in Obstructive Sleep Apnea Patients

This study will test if CPAP treatment and how severe someone's sleep apnea is affect optic nerve blood flow and the risk of ischemic optic neuropathy in adults with obstructive sleep apnea.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06748703 on ClinicalTrials.gov

What this trial studies

The trial will enroll 80 adults (ages 18–80) with newly diagnosed obstructive sleep apnea who have not previously received CPAP or OSA surgery. Participants will undergo baseline polysomnography to determine apnea-hypopnea index (AHI) and be grouped into mild, moderate, or severe OSA. Ophthalmologic testing will include optic nerve and macular blood-flow OCT, visual acuity, refraction, intraocular pressure, visual fields, and axial measurements. Eligible participants will receive CPAP treatment and be followed to compare ocular blood-flow measures and signs of ischemic optic neuropathy across severity groups and with treatment.

Who should consider this trial

Good fit: Adults 18–80 with a new diagnosis of OSA (AHI ≥ 5/h), who have not had prior CPAP or OSA surgery and can provide informed consent, are ideal candidates.

Not a fit: Patients with severe cerebrovascular disease, advanced vascular complications of diabetes, severe COPD, pulmonary hypertension, heart failure, pregnancy, or other major comorbidities are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could show that treating OSA with CPAP preserves or improves optic nerve blood flow and lowers the risk of ischemic optic neuropathy, potentially preventing vision loss.

How similar studies have performed: Smaller observational studies have reported associations between OSA and optic nerve ischemia and some ocular blood-flow changes with CPAP, but robust interventional evidence is still limited.

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Ning Ding,MD,PhD

Conditions: Obstructive Sleep Apnea, Ischemic Optic Neuropathy/Optic Nerve Stroke, Nonarteritic Ischemic Optic Neuropathy, CPAP treatment