Impulse Oscillometry for Prediction of PAP Titration Pressure in Obstructive Sleep Apnea (IOS-PAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Correlation between baseline impulse oscillometry (IOS) parameters (R5, X5, and Fres) and optimal CPAP pressure.
研究概览
简要总结
This prospective observational study aims to investigate whether impulse oscillometry (IOS)-a non-invasive lung function test-can help predict the specific pressure settings needed for positive airway pressure (PAP) therapy in patients with obstructive sleep apnea (OSA).
Currently, finding the optimal therapeutic pressure for OSA patients typically requires a titration process during sleep. This study explores if IOS parameters, which measure airway resistance and elasticity through small pressure oscillations during normal breathing, correlate with the final titration pressures (CPAP, EPAP, IPAP, and ΔP) determined by polysomnography.
Adult patients diagnosed with moderate-to-severe OSA (Apnea-Hypopnea Index ≥ 15) will undergo standard diagnostic sleep testing followed by IOS testing using the Vyaire Vyntus BodyBox® system. The researchers will evaluate whether these respiratory measurements can accurately predict required airway pressures and if they can help clinicians distinguish between patients who need Continuous Positive Airway Pressure (CPAP) versus Bilevel Positive Airway Pressure (BPAP) therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years
- •Diagnosed with obstructive sleep apnea (OSA) by overnight polysomnography (PSG)
- •Apnea-hypopnea index (AHI) ≥ 15
- •Undergoing positive airway pressure (PAP) titration (CPAP or BPAP)
- •Able to perform impulse oscillometry (IOS) test
- •Provided written informed consent
排除标准
- •Central sleep apnea
- •Neuromuscular disease or restrictive lung disease
- •Recent upper airway infection (< 2 weeks)
- •Incomplete PSG or IOS data
- •Inability to cooperate with testing procedures
研究组 & 干预措施
Moderate-to-Severe OSA Patients
Adult patients newly diagnosed with moderate-to-severe obstructive sleep apnea (AHI ≥ 15) who are scheduled to undergo an overnight PAP titration polysomnography. All participants in this single cohort will receive baseline impulse oscillometry (IOS) testing prior to their sleep study.
结局指标
主要结局
Correlation between baseline impulse oscillometry (IOS) parameters (R5, X5, and Fres) and optimal CPAP pressure.
时间窗: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks)
Evaluating the relationship between specific lung function parameters-specifically total airway resistance (R5), reactance (X5), and resonant frequency (Fres)-measured by a daytime IOS session, and the effective Continuous Positive Airway Pressure (CPAP) determined during the subsequent overnight titration study.
次要结局
- Discriminative ability of IOS parameters for CPAP versus BPAP treatment allocation.(From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).)
- Correlation between baseline IOS reactance parameters and bilevel pressure settings (IPAP/EPAP).(From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).)
研究者
Kadir Burak Akgün
Assistant Professor
Mustafa Kemal University