Obstructive Sleep Apnea (OSA)NCT06748703
Optic Nerve Injury in Obstructive Sleep Apnea Patients
A study testing CPAP Treatment in people with Obstructive Sleep Apnea (OSA) and Ischemic Optic Neuropathy/Optic Nerve Stroke, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Ischemic Optic Neuropathy/Optic Nerve Stroke
- What is being tested?
- CPAP Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Ning Ding, doctor, 86-25-68136723, dr.ningding@live.cn
About this study
Official title: Optic Nerve Injury and the Effect of CPAP Treatment in Obstructive Sleep Apnea Patients
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.
Read the detailed description
Ischemic optic neuropathy (ION) is damage to the optic nerve caused by ischemia and hypoxia in the optic nerve due to impairment of the blood supply of the arteries supplying the optic nerve. ION is an important blinding eye disease. It has been found that patients with OSAHS are often misdiagnosed as having normotensive glaucoma due to chronic hypoxia resulting in optic nerve ischemia and hypoxia, leading to the development of ION. However, the correlation between the two has been poorly studied and is uncertain due to the lack of accurate methods to evaluate blood flow.
The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University between the ages of 18-80 years. Participants will be diagnosed with OSA according to established guidelines and must be first-time visitors with no prior history of OSA surgery or CPAP treatment. Patients with severe cerebrovascular disease, psychiatric disorders, diagnosed diabetes mellitus with severe vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.
All participants will undergo a polysomnography (PSG) to determine the Apnea Hypopnea Index (AHI) and will be categorized into mild, moderate, or severe OSA groups. Ophthalmologic-related examinations will be performed to measure ocular parameters such as optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure (IOP), visual fields, and IOLMaster measurements of the eye axis.
Eligible patients will receive CPAP treatment for 3 months. After 3 months of CPAP treatment, participants will undergo another PSG examination with ophthalmologic correlation to re-evaluate sleep parameters and ocular parameters.
The collected data will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, minimum SPO2, hypoxic load, respiratory load, blood pressure variability, heart rate variability, pulse wave amplitude decline index, ESS drowsiness score, and the following ophthalmologic parameters: optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure, visual field, and eye axis as measured by IOLMaster. Paired t-tests will be performed to analyze the changes in the above indexes before and after CPAP treatment; ANOVA with repeated measurements will be performed to analyze the long-term changes in the above indexes.
The aim of this study is to analyze the relationship between sleep apnea severity hypoxia indexes and ION in OSAHS patients. To analyze the improvement of ischemic optic neuropathy (ION) after 3 months of CPAP treatment and to establish a long-term cohort to observe the occurrence of ION in patients with OSA of different severities, as well as the improvement of ION with long-term CPAP treatment.
- Being tested
- CPAP Treatment
- Keywords
- Obstructive Sleep Apnea, Nonarteritic Ischemic Optic Neuropathy, CPAP treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| CPAP Treatment Group | Experimental | Patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) who are eligible for CPAP therapy. Receives: Device: CPAP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 3 months of CPAP therapy
Apnea Hypopnea Index (AHI)
Number of apneas and hypoventilations per hour of sleep
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months of CPAP therapy
Secondary outcomes (9)
Time below 90% Saturation
Percentage of total time with oxygen saturation below 90% of total monitoring time.
Measured: Baseline and 3 months of CPAP therapy
Lowest SpO2 at night
The lowest SpO2 value recorded during the nightly test.
Measured: Baseline and 3 months of CPAP therapy
Mean SpO2
Mean SpO2 values during nighttime monitoring.
Measured: Baseline and 3 months of CPAP therapy
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.
Measured: Baseline and 3 months of CPAP therapy
Vision
The patient's naked eye visual acuity in the right and left eyes was checked using a visual acuity chart.
Measured: Baseline and 3 months of CPAP therapy
Diopter
Qualitative and quantitative analysis of the refractive status of the eye under test using computerized optometry.
Measured: Baseline and 3 months of CPAP therapy
Intraocular pressure
Measurement of intraocular pressure (IOP) in the eye under test using a non-contact tonometer.
Measured: Baseline and 3 months of CPAP therapy
Field of view
An automated visual field meter was used to detect the total loss of the visual field and the extent and depth of limiting defects in the tested eye.
Measured: Baseline and 3 months of CPAP therapy
Axon of the eye
The IOLMaster was utilized to measure the eye axis of the tested eye.
Measured: Baseline and 3 months of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Ding, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748703
- Sponsor's protocol ID
- 2024-SR-204
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared. The informed consent will be ansigned before enrolled in the study and ensured to keep personal information confidential.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Injury and the Effect of CPAP Treatment in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT06748703
- Acronym / sponsor ID
- 2024-SR-204
- Keywords
- Obstructive Sleep Apnea, Nonarteritic Ischemic Optic Neuropathy, CPAP treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ischemic optic neuropathy (ION) is damage to the optic nerve caused by ischemia and hypoxia in the optic nerve due to impairment of the blood supply of the arteries supplying the optic nerve. ION is an important blinding eye disease. It has been found that patients with OSAHS are often misdiagnosed as having normotensive glaucoma due to chronic hypoxia resulting in optic nerve ischemia and hypoxia, leading to the development of ION. However, the correlation between the two has been poorly studied and is uncertain due to the lack of accurate methods to evaluate blood flow.
The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University between the ages of 18-80 years. Participants will be diagnosed with OSA according to established guidelines and must be first-time visitors with no prior history of OSA surgery or CPAP treatment. Patients with severe cerebrovascular disease, psychiatric disorders, diagnosed diabetes mellitus with severe vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.
All participants will undergo a polysomnography (PSG) to determine the Apnea Hypopnea Index (AHI) and will be categorized into mild, moderate, or severe OSA groups. Ophthalmologic-related examinations will be performed to measure ocular parameters such as optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure (IOP), visual fields, and IOLMaster measurements of the eye axis.
Eligible patients will receive CPAP treatment for 3 months. After 3 months of CPAP treatment, participants will undergo another PSG examination with ophthalmologic correlation to re-evaluate sleep parameters and ocular parameters.
The collected data will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, minimum SPO2, hypoxic load, respiratory load, blood pressure variability, heart rate variability, pulse wave amplitude decline index, ESS drowsiness score, and the following ophthalmologic parameters: optic nerve and macular blood flow OCT, visual acuity, refraction, intraocular pressure, visual field, and eye axis as measured by IOLMaster. Paired t-tests will be performed to analyze the changes in the above indexes before and after CPAP treatment; ANOVA with repeated measurements will be performed to analyze the long-term changes in the above indexes.
The aim of this study is to analyze the relationship between sleep apnea severity hypoxia indexes and ION in OSAHS patients. To analyze the improvement of ischemic optic neuropathy (ION) after 3 months of CPAP treatment and to establish a long-term cohort to observe the occurrence of ION in patients with OSA of different severities, as well as the improvement of ION with long-term CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP Treatment Group | Experimental | Device: CPAP TreatmentPatients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) who are eligible for CPAP therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP TreatmentCPAP 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. | Device | CPAP Treatment Group |
Primary outcome
Optic nerve and macular blood flow
Time frame: 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)
Time frame: Baseline and 3 months of CPAP therapy
Number of apneas and hypoventilations per hour of sleep
Hypoxic Burden（HB）
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Time below 90% Saturation
Time frame: Baseline and 3 months of CPAP therapy
Lowest SpO2 at night
Time frame: Baseline and 3 months of CPAP therapy
Mean SpO2
Time frame: Baseline and 3 months of CPAP therapy
Oxygen Desaturation Index
Time frame: Baseline and 3 months of CPAP therapy
Vision
Time frame: Baseline and 3 months of CPAP therapy
Diopter
Time frame: Baseline and 3 months of CPAP therapy
Intraocular pressure
Time frame: Baseline and 3 months of CPAP therapy
Field of view
Time frame: Baseline and 3 months of CPAP therapy
Axon of the eye
Time frame: Baseline and 3 months of CPAP therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared. The informed consent will be ansigned before enrolled in the study and ensured to keep personal information confidential.
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Treatment in people with Obstructive Sleep Apnea (OSA) and Ischemic Optic Neuropathy/Optic Nerve Stroke, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Ding,MD,PhD (86-25-68136723, dr.ningding@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve and macular blood flow (time frame: Baseline and 3 months of CPAP therapy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.