Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Withings
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG
研究概览
简要总结
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.
Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.
The Withings Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep for the detection of SAS compared to PSG.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults, men or women, aged between 18 and 70
- •patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing
排除标准
- •children less than 18 years of age
- •patients treated with continuous positive airway pressure
- •person not giving her consent
- •vulnerable subject according to current regulation:
- •pregnant woman, parturient or breastfeeding
- •subject deprived of freedom by judicial, medical or administrative decision
- •subject legally protected or unable to express his consent
- •subject non-beneficiary of healthcare
- •subject falling into more than one of the above categories
- •subject in linguistic or psychic incapacity to express his consent
研究组 & 干预措施
Patients referred for an overnight in-lab PSG
Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG
结局指标
主要结局
Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG
时间窗: immediately after intervention
Sensitivity and specificity for SAS detection by Withings Sleep compared to polysomnography (PSG) at apnea-hypopnea index (AHI) threshold value of 15/h in PSG.
Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG
时间窗: immediately after intervention
Sensitivity and specificity for SAS detection by Withings Sleep compared to PSG at AHI threshold value of 30/h in PSG.
次要结局
- Sensitivity and specificity of polygraphy (PG)(immediately after intervention)
- Sensitivity and specificity of PG(immediately after intervention)
- Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG(immediately after intervention)
- Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG(immediately after intervention)
- Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG(immediately after intervention)
- Influence of the position of the sleeper (decubitus dorsal vs decubitus latero-ventral) on the error of the AHI predicted by Withings Sleep compared with PSG(immediately after intervention)
- Impact of the proportion of hypopnea events on the performance of Withings Sleep(immediately after intervention)
- Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.(immediately after intervention)
- Reliability of Withings Sleep(immediately after intervention)
- Reliability of PSG(immediately after intervention)