Pilot Study of Innovative Sleep Quality Analysis Software Compared With Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
To diagnose sleep disorders, practitioners primarily use polysomnography (PSG), a precise but costly, cumbersome method that is limited to a single observation. This does not allow for longitudinal monitoring of sleep habits in real-world conditions. An alternative is offered with the C. Santé software receiving information from sensors installed on medical bed. This software analyzes cardiorespiratory parameters and sleep phases without disturbing the patient, enabling continuous and comfortable monitoring. A preliminary study aims to validate the reliability of the C. Santé software analysis, by comparing it to the PSG analysis, considered the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult patients aged over 18 years.
- •Patients affiliated with or beneficiaries of a social security system.
- •Patients capable of completing all aspects of the study.
- •Patients who have signed informed consent for participation in the study
排除标准
- •pregnancy
- •Patients suffering from an acute bacterial, fungal, or viral infection.
- •Patients unable to tolerate the placement of the PSG.
- •Patients with psychiatric disorders incompatible with the constraints associated with the need to spend two nights at the clinic.
- •restless legs syndrome
- •Presence of a cardiac pacemaker.
- •Cardiac arrhythmia problems (e.g., complete arrhythmia).
- •Known and treated sleep disorders (e.g., sleep apnea syndrome) or uncontrolled chronic insomnia.
- •Diagnosed dementia.
- •Simultaneous participation in other research studies.
- •Use of medications that could alter sleepiness, including:
- •Sedative-hypnotics.
- •Neuroleptics.
- •Antidepressants.
- •Anxiolytics.
- •H1 antihistamines.
- •Antiepileptics.
- •Opiates and opioid analgesics.
- •Patients under legal guardianship or curatorship.
研究组 & 干预措施
Polysomnography
The patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional polysomnography.
干预措施: C. Santé software compared to polysomnography (Diagnostic Test)