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Optic Nerve Injury in Obstructive Sleep Apnea Patients

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 27, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study description expanded, about 8 words
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06748703
Lead Sponsor Nanjing Medical University
Conditions
(from sponsor)
Obstructive Sleep Apnea (OSA), Ischemic Optic Neuropathy/Optic Nerve Stroke
Related terms Optic Neuropathy, Ischemic, Sleep Apnea, Obstructive
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov