Obstructive Sleep ApneaXOR-OSANCT06554496
XOR Levels in OSA Patients (XOR-OSA)
A study testing CPAP Treatment in people with Obstructive Sleep Apnea, run by Nanjing Medical University at 1 site in China.
Trial summary
The level of xanthine oxidoreductase (XOR) in plasma is associated with oxidative stress and inflammation. Obstructive Sleep Apnea (OSA) is characterized by repeated upper airway obstruction and apneas during sleep, leading to chronic intermittent hypoxemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- 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 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
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
Ning Ding, doctor
About this study
Official title: Obstructive Sleep Apnea Severity and Xanthine Oxidoreductase Activity: Mechanisms and Clinical Implications
The level of xanthine oxidoreductase (XOR) in plasma is associated with oxidative stress and inflammation. Obstructive Sleep Apnea (OSA) is characterized by repeated upper airway obstruction and apneas during sleep, leading to chronic intermittent hypoxemia. The specific role of XOR in OSA, its relationship with the severity of OSA, and the changes in XOR levels before and after CPAP treatment remain unclear. The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University, categorized by their Apnea-Hypopnea Index (AHI) into mild, moderate, and severe OSA groups. Participants will undergo baseline assessments including polysomnography (PSG) and measurements of XOR activity and biomarkers such as uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), and inflammatory markers. Eligible patients will receive CPAP treatment for 3 months, after which their XOR activity and biomarker levels will be re-evaluated to assess treatment efficacy.
Read the detailed description
Xanthine oxidoreductase (XOR) is an enzyme involved in the oxidative metabolism of purines, producing reactive oxygen species (ROS) as byproducts. Elevated XOR activity is associated with increased oxidative stress and inflammation. In patients with Obstructive Sleep Apnea(OSA), repeated episodes of hypoxia and reoxygenation lead to oxidative stress and inflammatory responses. However, the specific changes in XOR activity in OSA patients are not well understood.
This study aims to evaluate the effects of Continuous Positive Airway Pressure (CPAP) treatment on patients with OSA by analyzing XOR activity and related biomarkers. The primary objective is to assess the correlation between XOR activity levels and the severity of OSA, and to determine how these levels change following a 3-month CPAP intervention.
The study will enroll 80 patients aged 18-80 years from the First Affiliated Hospital of Nanjing Medical University. Participants will be diagnosed with OSA according to established guidelines, and must be first-time visitors with no prior OSA surgery or CPAP treatment history. Patients with severe cerebrovascular diseases, psychiatric conditions, diagnosed diabetes with significant vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.
All participants will undergo polysomnography (PSG) to determine the Apnea-Hypopnea Index (AHI) and categorize them into mild, moderate, or severe OSA groups.
Blood samples will be collected to measure baseline XOR activity and related biomarkers, including uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), malondialdehyde (MDA), superoxide dismutase (SOD), hypoxia-inducible factor-1 (HIF-1), and angiotensin II (Ang II).
Eligible patients will receive CPAP therapy for a duration of 3 months. Patients unsuitable for CPAP therapy will receive alternative treatments such as upper airway surgery, oral appliances, or weight reduction programs. After 3 months of CPAP therapy, participants will undergo follow-up PSG to reassess sleep parameters. Blood samples will be collected again to measure changes in XOR activity and related biomarkers.
The data collected will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, lowest SpO2, oxygen load, blood pressure load, ESS sleepiness scores, and XOR levels. Paired t-tests will be used to compare pre- and post-treatment XOR activity and biomarker levels. Repeated measures ANOVA will be conducted to evaluate the long-term changes and sustained effects of CPAP therapy.
This study aims to provide a comprehensive understanding of the biochemical impacts of CPAP therapy on patients with OSAHS. The findings are expected to identify potential biomarkers for assessing treatment efficacy and to guide future therapeutic strategies, ultimately improving patient outcomes in clinical practice.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP Treatment
- Keywords
- Obstructive Sleep Apnea, Xanthine Oxidoreductase, CPAP treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TreatmentDevice
Continuous Positive Airway Pressure (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 Continuous Positive Airway Pressure (CPAP) therapy. Receives: Device: CPAP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xanthine Oxidoreductase (XOR) Activity
To measure changes in XOR activity levels in OSA patients with different severities, using enzyme-linked immunosorbent assay (ELISA) techniques, before and after 3 months of CPAP therapy, reported in units per liter (U/L).
Measured: Baseline and 3 months of CPAP therapy
Apnea-Hypopnea Index (AHI)
To measure changes in the Apnea-Hypopnea Index, quantifying the severity of sleep apnea, reported as the number of apneas and hypopneas per hour of sleep.
Measured: Baseline and 3 months of CPAP therapy.
Secondary outcomes (6)
Uric Acid Levels
Assess changes in serum uric acid levels, reported in milligrams per deciliter (mg/dL), using ELISA.
Measured: Baseline and 3 months of CPAP therapy
Endothelial Nitric Oxide Synthase (eNOS) Activity
Measure changes in eNOS activity in serum, reported in units per liter (U/L), using ELISA.
Measured: Baseline and 3 months of CPAP therapy
C-Reactive Protein (CRP) Levels
Measure changes in C-reactive protein levels in serum, reported in milligrams per liter (mg/L), using ELISA.
Measured: Baseline and 3 months of CPAP therapy
Superoxide Dismutase (SOD) Activity
Assess changes in superoxide dismutase activity in serum, reported in units per milliliter (U/mL), using ELISA.
Measured: Baseline and 3 months of CPAP therapy.
Time with Oxygen Saturation Below 90% (T90%)
To measure the duration of time spent with oxygen saturation levels below 90% during sleep, reported as a percentage of total sleep time with SpO2 below 90%.
Measured: Baseline and 3 months of CPAP therapy.
Subjective Sleepiness
To assess changes in subjective sleepiness using the Epworth Sleepiness Scale (ESS), which is a self-administered questionnaire. The ESS measures the general level of daytime sleepiness, or average sleep propensity in daily activities, on a scale ranging from 0 to 24. A higher score on this scale indicates a greater likelihood of falling asleep in a variety of situations, suggesting worse daytime sleepiness.
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 posted15 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- NCT06554496
- Sponsor's protocol ID
- 2024-SR-629
- Acronym
- XOR-OSA
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 16 Aug 2024
- 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.
Publications
Bortolotti M, Polito L, Battelli MG, Bolognesi A. Xanthine oxidoreductase: One enzyme for multiple physiological tasks. Redox Biol. 2021 May;41:101882. doi: 10.1016/j.redox.2021.101882. Epub 2021 Jan 27.
PubMed 33578127Saugstad OD. Role of xanthine oxidase and its inhibitor in hypoxia: reoxygenation injury. Pediatrics. 1996 Jul;98(1):103-7.
PubMed 8668378Ali MH, Schlidt SA, Chandel NS, Hynes KL, Schumacker PT, Gewertz BL. Endothelial permeability and IL-6 production during hypoxia: role of ROS in signal transduction. Am J Physiol. 1999 Nov;277(5):L1057-65. doi: 10.1152/ajplung.1999.277.5.L1057.
PubMed 10564193Vickneson K, George J. Xanthine Oxidoreductase Inhibitors. Handb Exp Pharmacol. 2021;264:205-228. doi: 10.1007/164_2020_383.
PubMed 32789757Nguyen NH, Tran GB, Nguyen CT. Anti-oxidative effects of superoxide dismutase 3 on inflammatory diseases. J Mol Med (Berl). 2020 Jan;98(1):59-69. doi: 10.1007/s00109-019-01845-2. Epub 2019 Nov 13.
PubMed 31724066
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Severity and Xanthine Oxidoreductase Activity: Mechanisms and Clinical Implications
- ClinicalTrials.gov ID
- NCT06554496
- Acronym / sponsor ID
- XOR-OSA / 2024-SR-629
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Xanthine Oxidoreductase, CPAP treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Aug 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.
The level of xanthine oxidoreductase (XOR) in plasma is associated with oxidative stress and inflammation. Obstructive Sleep Apnea (OSA) is characterized by repeated upper airway obstruction and apneas during sleep, leading to chronic intermittent hypoxemia. The specific role of XOR in OSA, its relationship with the severity of OSA, and the changes in XOR levels before and after CPAP treatment remain unclear. The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University, categorized by their Apnea-Hypopnea Index (AHI) into mild, moderate, and severe OSA groups. Participants will undergo baseline assessments including polysomnography (PSG) and measurements of XOR activity and biomarkers such as uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), and inflammatory markers. Eligible patients will receive CPAP treatment for 3 months, after which their XOR activity and biomarker levels will be re-evaluated to assess treatment efficacy.
Detailed description
Xanthine oxidoreductase (XOR) is an enzyme involved in the oxidative metabolism of purines, producing reactive oxygen species (ROS) as byproducts. Elevated XOR activity is associated with increased oxidative stress and inflammation. In patients with Obstructive Sleep Apnea(OSA), repeated episodes of hypoxia and reoxygenation lead to oxidative stress and inflammatory responses. However, the specific changes in XOR activity in OSA patients are not well understood.
This study aims to evaluate the effects of Continuous Positive Airway Pressure (CPAP) treatment on patients with OSA by analyzing XOR activity and related biomarkers. The primary objective is to assess the correlation between XOR activity levels and the severity of OSA, and to determine how these levels change following a 3-month CPAP intervention.
The study will enroll 80 patients aged 18-80 years from the First Affiliated Hospital of Nanjing Medical University. Participants will be diagnosed with OSA according to established guidelines, and must be first-time visitors with no prior OSA surgery or CPAP treatment history. Patients with severe cerebrovascular diseases, psychiatric conditions, diagnosed diabetes with significant vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.
All participants will undergo polysomnography (PSG) to determine the Apnea-Hypopnea Index (AHI) and categorize them into mild, moderate, or severe OSA groups.
Blood samples will be collected to measure baseline XOR activity and related biomarkers, including uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), malondialdehyde (MDA), superoxide dismutase (SOD), hypoxia-inducible factor-1 (HIF-1), and angiotensin II (Ang II).
Eligible patients will receive CPAP therapy for a duration of 3 months. Patients unsuitable for CPAP therapy will receive alternative treatments such as upper airway surgery, oral appliances, or weight reduction programs. After 3 months of CPAP therapy, participants will undergo follow-up PSG to reassess sleep parameters. Blood samples will be collected again to measure changes in XOR activity and related biomarkers.
The data collected will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, lowest SpO2, oxygen load, blood pressure load, ESS sleepiness scores, and XOR levels. Paired t-tests will be used to compare pre- and post-treatment XOR activity and biomarker levels. Repeated measures ANOVA will be conducted to evaluate the long-term changes and sustained effects of CPAP therapy.
This study aims to provide a comprehensive understanding of the biochemical impacts of CPAP therapy on patients with OSAHS. The findings are expected to identify potential biomarkers for assessing treatment efficacy and to guide future therapeutic strategies, ultimately improving patient outcomes in clinical practice.
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 Continuous Positive Airway Pressure (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 TreatmentContinuous Positive Airway Pressure (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. | Device | CPAP Treatment Group |
Primary outcome
Xanthine Oxidoreductase (XOR) Activity
Time frame: Baseline and 3 months of CPAP therapy
To measure changes in XOR activity levels in OSA patients with different severities, using enzyme-linked immunosorbent assay (ELISA) techniques, before and after 3 months of CPAP therapy, reported in units per liter (U/L).
Apnea-Hypopnea Index (AHI)
Time frame: Baseline and 3 months of CPAP therapy.
To measure changes in the Apnea-Hypopnea Index, quantifying the severity of sleep apnea, reported as the number of apneas and hypopneas per hour of sleep.
6 secondary outcomes
Uric Acid Levels
Time frame: Baseline and 3 months of CPAP therapy
Endothelial Nitric Oxide Synthase (eNOS) Activity
Time frame: Baseline and 3 months of CPAP therapy
C-Reactive Protein (CRP) Levels
Time frame: Baseline and 3 months of CPAP therapy
Superoxide Dismutase (SOD) Activity
Time frame: Baseline and 3 months of CPAP therapy.
Time with Oxygen Saturation Below 90% (T90%)
Time frame: Baseline and 3 months of CPAP therapy.
Subjective Sleepiness
Time frame: Baseline and 3 months of CPAP therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Results publication: PubMed 33578127Bortolotti M, Polito L, Battelli MG, Bolognesi A. Xanthine oxidoreductase: One enzyme for multiple physiological tasks. Redox Biol. 2021 May;41:101882. doi: 10.1016/j.redox.2021.101882. Epub 2021 Jan 27.
- Results publication: PubMed 8668378Saugstad OD. Role of xanthine oxidase and its inhibitor in hypoxia: reoxygenation injury. Pediatrics. 1996 Jul;98(1):103-7.
- Results publication: PubMed 10564193Ali MH, Schlidt SA, Chandel NS, Hynes KL, Schumacker PT, Gewertz BL. Endothelial permeability and IL-6 production during hypoxia: role of ROS in signal transduction. Am J Physiol. 1999 Nov;277(5):L1057-65. doi: 10.1152/ajplung.1999.277.5.L1057.
- Results publication: PubMed 32789757Vickneson K, George J. Xanthine Oxidoreductase Inhibitors. Handb Exp Pharmacol. 2021;264:205-228. doi: 10.1007/164_2020_383.
- Results publication: PubMed 31724066Nguyen NH, Tran GB, Nguyen CT. Anti-oxidative effects of superoxide dismutase 3 on inflammatory diseases. J Mol Med (Berl). 2020 Jan;98(1):59-69. doi: 10.1007/s00109-019-01845-2. Epub 2019 Nov 13.
- 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.
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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. This study is not recruiting at the moment.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
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, 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xanthine Oxidoreductase (XOR) Activity (time frame: Baseline and 3 months of CPAP therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554496, which also lists 5 linked publications.
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 16 Aug 2024.