A Prospective, Multicentre, Randomised, Blinded Study of Obstructive Sleep Apnoea Detection Using the Sunrise Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Time to treatment decision
研究概览
简要总结
A prospective, randomised, blinded pilot study comparing the Sunrise solution and overnight polygraphy for the diagnosis of OSA in adult patients. Patients under investigation for OSA will use both devices simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. A retrospective check of their diagnosis will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Patients under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. They will be unaware of which device their treatment decision was based on.
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
- •Ability and willingness to provide informed consent
- •Patient referred for suspected OSA
- •BMI >28 kg/m2
- •Epworth Sleepiness Score >12
- •Reported snoring (criterion may be ignored if patient sleeps alone)
- •Patient able to use a smartphone application and having an internet connection at home
排除标准
- •Patient already treated for OSA
- •Patient has PSV or HGV driving license
- •Unstable cardiac disease
- •Supplemental oxygen
- •Known secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome
- •Concerns about sleepy driving or any other potentially dangerous symptom from physician or urgent referral from GP when patient has been told to stop driving
- •Pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- •Patient whose beard is too thick to wear the Sunrise device, and who does not wish to shave
- •Patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint
结局指标
主要结局
Time to treatment decision
时间窗: From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months
Time (days) from sleep study device dispatch to treatment decision
次要结局
- AHI(After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months)
- Time to treatment decision; RBH vs NHS Scotland Sleep Service(From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months)