Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Effectiveness of a positional device (PD) (NightBalance, Philips) compared to continuous positive airway pressure (CPAP) in the treatment of OSA assessed by the intergroup differences in apnea hypopnea index (AHI) measured by respiratory polygraphy (RP)
研究概览
简要总结
The objectives of this study are:
- To assess the effectiveness and cost-effectiveness of a vibrating positional device (NightBalance, Philips) in the treatment of positional obstructive sleep apnea compared to conventional CPAP treatment.
- To investigate whether a positional device (NightBalance, Philips) avoids supine position after a period of use of the device without actively using the device for a subsequent period of time.
详细描述
Non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (PD) and CPAP to evaluate the effectiveness of treatment of positional obstructive sleep apnea with a PD (NightBalance, Philips) compared to CPAP after 6 months of continuous treatment (first phase) and the permanence of such efficacy after subsequent discontinuation of treatment (second phase).
An initial respiratory polygraphy will be performed in all patients and the sleep study will be repeated at 6 months with PD and CPAP. After its withdrawal, in those patients who respond, the respiratory polygraphy will be repeated at one week and one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients over 18 years of age.
- •Signed informed consent.
- •Diagnosis of POSA by respiratory polygraphy with the following criteria:
- •AHI ≥ 15/h or AHI ≥ 10/h and AHI <15/h with an Epworth >10
- •AHI ns <10/h (<5/h in mild OSA).
- •AHI is at least twice the AHI in ns
- •Time in supine >20%.
- •Valid recording time>4h
排除标准
- •Treatment of OSA with CPAP or DAM in the previous month or treatment with surgery for OSA at any time.
- •Presence of other sleep disorders or central sleep apnea (central AHI >50% of total AHI).
- •Severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use.
- •Poorly controlled arterial hypertension or refractory arterial hypertension.
- •Condition that makes it difficult or impossible to change position during sleep.
- •Epworth scale score ≥
- •Professional driver, heavy machinery operator or shift worker.
- •Pregnancy.
- •Treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
研究组 & 干预措施
Positional Device (PD)
Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea
干预措施: Positional device (PD) (Device)
Continuos Positive Airway Pressure (CPAP)
Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea
干预措施: Continuos Positive Airway Pressure (CPAP) (Device)
结局指标
主要结局
Effectiveness of a positional device (PD) (NightBalance, Philips) compared to continuous positive airway pressure (CPAP) in the treatment of OSA assessed by the intergroup differences in apnea hypopnea index (AHI) measured by respiratory polygraphy (RP)
时间窗: 6 months
To evaluate the effectiveness of a positional device (PD) (NightBalance, Philips) compared to continuous positive airway pressure (CPAP) in the treatment of OSA by assessing the apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 6 months of treatment in a non-inferiority analysis.
次要结局
- Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the AIH measured by RP.(6 months)
- Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the quality-adjusted life years measured by the EuroQol-5D questionnaire(6 months)
- Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account health resources consumed.(6 months)
- Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the degree of daytime sleepiness measured by the Epworth scale.(6 months)
- Conditioned response of PD assesed by the apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 1 week and 1 month of withdrawing active treatment(1 month)
研究者
Irene Cano-Pumarega
Sleep Unit Coordinator, Principal Investigator, Clinical Professor
Hospital Universitario Ramon y Cajal