Optic Nerve Injury in Obstructive Sleep Apnea Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

CPAP 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.

Study 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

Primary outcome measure(s)

• Optic nerve and macular blood flow — Baseline and 3 months of CPAP therapy
  Changes in optic nerve and macular blood flow in patients with OSA of varying severity were measured using blood flow optical coherence tomography (blood flow OCT).
• Apnea Hypopnea Index (AHI) — Baseline and 3 months of CPAP therapy
  Number of apneas and hypoventilations per hour of sleep
• Hypoxic Burden（HB） — Baseline and 3 months of CPAP therapy
  The sum of the area between the SpO2 trace and the desaturation baseline associated with all apnoea and hypopnoea events is divided by the total time of sleep.
• Ventilatory burden — Baseline and 3 months of CPAP therapy
  The average ventilatory burden per event was defined as the multiplication of the average ventilation during the respiratory event and average duration of respiratory events. The total ventilatory burden for each participant was defined as the multiplication of respiratory event rate and average ventilatory area per event.
• Blood pressure variability — Baseline and 3 months of CPAP therapy
  The main studies were on ultrashort-term variability (blood pressure variability between each heart beat) and short-term variability (blood pressure variability over a 24-hour period).
• Heart rate variability — Baseline and 3 months of CPAP therapy
  Heart rate variability (HRV) is the variation of differences between consecutive cardiac cycles. For example, the standard deviation of NN intervals in 24 h (SDNN), the standard deviation of the mean of NN intervals per 5 min (SDANN), and the SDNN during wakefulness and sleep.
• Pulse Wave Amplitude Drops Index — Baseline and 3 months of CPAP therapy
  The number of decreases (\>30%) in pulse wave amplitude per hour detected by pulse oximetry based on photoplethysmographic volumetric tracing (PPG) signals during sleep.

Trial sites (1)

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