XOR Levels in OSA Patients (XOR-OSA)

NCT06554496 | Recruiting DMC

• 1 other identifier: 2024-SR-629
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Xanthine Oxidoreductase; CPAP treatment

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline and 3 months of CPAP therapy.

Secondary Outcomes (6)

• Uric Acid Levels

  Baseline and 3 months of CPAP therapy

• Endothelial Nitric Oxide Synthase (eNOS) Activity

  Baseline and 3 months of CPAP therapy

• C-Reactive Protein (CRP) Levels

  Baseline and 3 months of CPAP therapy

• Superoxide Dismutase (SOD) Activity

  Baseline and 3 months of CPAP therapy.

• Time with Oxygen Saturation Below 90% (T90%)

  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 Continuous Positive Airway Pressure (CPAP) therapy.

Device: CPAP Treatment

Interventions

CPAP Treatment DEVICE

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.

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

Related Publications (5)

• 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.

  PMID: 33578127 RESULT

• Saugstad OD. Role of xanthine oxidase and its inhibitor in hypoxia: reoxygenation injury. Pediatrics. 1996 Jul;98(1):103-7.

  PMID: 8668378 RESULT

• Ali 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.

  PMID: 10564193 RESULT

• Vickneson K, George J. Xanthine Oxidoreductase Inhibitors. Handb Exp Pharmacol. 2021;264:205-228. doi: 10.1007/164_2020_383.

  PMID: 32789757 RESULT

• Nguyen 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.

  PMID: 31724066 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

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

Intervention Hierarchy (Ancestors)

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

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: August 6, 2024
• First Posted: August 15, 2024
• Study Start: July 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)