Optic Nerve Injury in Obstructive Sleep Apnea Patients

NCT06748703 | Recruiting DMC

• 1 other identifier: 2024-SR-204
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA); Ischemic Optic Neuropathy/Optic Nerve Stroke

Keywords

Obstructive Sleep Apnea; Nonarteritic Ischemic Optic Neuropathy; CPAP treatment

Outcome Measures

Primary Outcomes (7)

• 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).

  Baseline and 3 months of CPAP therapy

• Apnea Hypopnea Index (AHI)

  Number of apneas and hypoventilations per hour of sleep

  Baseline and 3 months of CPAP therapy

• 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.

  Baseline and 3 months of CPAP therapy

• 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.

  Baseline and 3 months of CPAP therapy

• Blood pressure variability

  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).

  Baseline and 3 months of CPAP therapy

• Heart rate variability

  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.

  Baseline and 3 months of CPAP therapy

• Pulse Wave Amplitude Drops Index

  The number of decreases (\>30%) in pulse wave amplitude per hour detected by pulse oximetry based on photoplethysmographic volumetric tracing (PPG) signals during sleep.

  Baseline and 3 months of CPAP therapy

Secondary Outcomes (9)

• Time below 90% Saturation

  Baseline and 3 months of CPAP therapy

• Lowest SpO2 at night

  Baseline and 3 months of CPAP therapy

• Mean SpO2

  Baseline and 3 months of CPAP therapy

• Oxygen Desaturation Index

  Baseline and 3 months of CPAP therapy

• Vision

  Baseline and 3 months of CPAP therapy

Study Arms (1)

CPAP Treatment Group

EXPERIMENTAL

Patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) who are eligible for CPAP therapy.

Device: CPAP Treatment

Interventions

CPAP Treatment DEVICE

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.

CPAP Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Optic Neuropathy, Ischemic

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Ning Ding,MD,PhD

CONTACT

86-25-68136723; dr.ningding@live.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)