RecruitingNot ApplicableNCT06748703

Optic Nerve Injury in Obstructive Sleep Apnea Patients

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


Sponsor

Nanjing Medical University

Enrollment

80 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

DEVICECPAP 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.


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06748703


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