New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
研究概览
简要总结
Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by intermittent partial and/or complete upper airway obstruction during sleep. The participants, naive to nasal continuous positive airway pressure (CPAP), recently diagnosed with OSA, will undergo two automatic CPAP titration studies with collection of polysomnographic (PSG) data. The data will be analysed to assess effectiveness of Compumedics auto-CPAP device in the normalisation of sleep disordered breathing in OSA patients, with respect to another auto-CPAP device.
详细描述
Auto-titrating CPAP (APAP) using algorithms based on detection of flow limitation and snoring have been developed. Auto-titration devices adjust nasal pressure to the minimum pressure needed to maintain airway patency at any point in time and can accommodate a range of background states that affect airway collapsibility and hence CPAP pressure requirement including sedation, alcohol, airway inflammation, body position and sleep state.
Compumedics Limited has developed an APAP device (Somnilink SPAP based on the new algorithm technology of characterising breaths and determination of inspiratory flow limitation. The objectives of this new technology are to enable accurate detection of inspiratory intervals for irregular breathing patterns that are likely to occur during REM sleep, sleep onset and wakefulness as well as to provide correct characterisation of inspiratory flow limitation. These features could translate in delivery of superior treatment because of improved sensitivity and specificity of respiratory event detection and earlier pressure response to inspiratory flow limitation. Demonstration of superiority of the Somnilink SPAP device relative to existing APAP treatment devices will be subject of future clinical trials (beyond the scope of this protocol). An early clinical trial of a pre-production version of Somnilink SPAP with the pressure control algorithm identical to the production version established non-inferiority for AHI relative to a reference APAP (Resmed Autoset Spirit) with the differential AHI estimate of -0.91 [-2.80; 0.91] (Mean [95%CI]). The Somnilink SPAP device is now available as a production version (CE and TGA approved) and the purpose of the current study is to establish its non-inferiority compared to an existing APAP device (Resmed Autoset S8).
The treatment will be administered on the two nights of polysomnographic studies (PSG) by means of continuous air pressure delivery under the variable pressure levels determined by the APAP device to maintain the upper airway patency.
The population of adult patients newly diagnosed with OSA after undergoing a diagnostic PSG study in the sleep laboratory with no previous CPAP treatment experience and complying with the eligibility criteria (as outlined below) will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than
- •Ability to give informed consent.
- •OSA diagnosis and referral for clinical CPAP implementation at the Monash Sleep Centre within 3 months of recruitment.
排除标准
- •Inability to give informed consent.
- •Significant central sleep apnea (AHI for central events >= 5).
- •Congestive heart failure.
- •Co-existing obesity related hypoventilation.
- •Nasal obstruction, mouth breathing or other anatomical or physiological conditions making CPAP therapy inappropriate.
- •History of prior CPAP treatment.
- •Previous reaction to skin preparation, tapes and electrode gels used at PSG.
结局指标
主要结局
Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
时间窗: Up to 8 weeks after study completion
AHI is the number of apnea and hypopnea events per hour of sleep
次要结局
- AHI difference between test treatment and baseline(Up to 8 weeks after study completion)
- Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline(Up to 8 weeks after study completion)
- Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline(Up to 8 weeks after study completion)
- Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline(Up to 8 weeks after study completion)
- Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline(Up to 8 weeks after study completion)
- Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.(The patients fill KSS questionnaire immediately after each PSG study)
- Test treatment AHI(Up to 8 weeks after study completion)