Optic Nerve Injury in Obstructive Sleep Apnea Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CPAP Treatment
DeviceCPAP 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: CPAP Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Optic nerve and macular blood flow
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).
Time frame
Baseline and 3 months of CPAP therapy2
Apnea Hypopnea Index (AHI)
Number of apneas and hypoventilations per hour of sleep
Time frame
Baseline and 3 months of CPAP therapy3
Hypoxic Burden（HB）
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.
Time frame
Baseline and 3 months of CPAP therapy4
Ventilatory burden
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.
Time frame
Baseline and 3 months of CPAP therapySecondary outcomes
1
Time below 90% Saturation
Percentage of total time with oxygen saturation below 90% of total monitoring time.
Time frame
Baseline and 3 months of CPAP therapy2
Lowest SpO2 at night
The lowest SpO2 value recorded during the nightly test.
Time frame
Baseline and 3 months of CPAP therapy3
Mean SpO2
Mean SpO2 values during nighttime monitoring.
Time frame
Baseline and 3 months of CPAP therapy4
Oxygen Desaturation Index
The number of oxygen desaturation events per hour of sleep.The desaturation thresholds of 3% (ODI3) or 4% (ODI4) are commonly chosen in the analysis of OSA.
Time frame
Baseline and 3 months of CPAP therapySponsors and contacts
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Source ClinicalTrials.gov