Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Participant-Reported Experience with the SleepImage Device
研究概览
简要总结
Background:
Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis.
Devices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate.
The study:
This study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main/definitive study.
The main study aims to assess the diagnostic agreement between the devices and will be registered independently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Age 18 years or above
- •Diagnosed with type 2 diabetes mellitus
- •Resident in Region Zealand, Denmark
- •Understand and speak Danish
排除标准
- •Previously undergone surgery for OSA
- •Currently or within the last month used treatment for OSA such as CPAP, sleep position trainer, mandibular advancement devices etc.
- •Having an Implanted Cardioverter Defibrillator (ICD)
- •Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices
研究组 & 干预措施
Pilot study
Single-arm testing the feasibility of conducting a clinical trial testing three different home sleep apnea tests in patients with type 2 diabetes.
干预措施: Home Sleep Apnea Test (Device)
结局指标
主要结局
Participant-Reported Experience with the SleepImage Device
时间窗: Day 3 (after two nights of home monitoring, before the third night).
Assessed identically to Outcome 1 for the SleepImage Device.
Proportion of Analyzable Recordings by Device
时间窗: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 10 weeks after enrollment
For each device (NightOwl, SleepImage, Nox T3), the number of nights yielding an analyzable recording meeting predefined technical criteria, divided by the number of nights the device was worn, expressed as a percentage. The complementary proportion of failed, incomplete, or non-analyzable recordings is reported per device.
Participant-Reported Experience with the NightOwl Device
时间窗: Day 3 (after two nights of home monitoring, before the third night).
Participant-reported experience with the NightOwl device, assessed at Day 3 with a study-specific questionnaire. Items are rated on a 0-100 visual analog scale (0 = completely disagree, 100 = completely agree) and span four dimensions: 1) device usability (overall ease of use, learnability, adequacy of information, adherence to instructions, interference with daily life, sleep disturbance), 2) sensor application and overnight fit, 3) smartphone-application comprehensibility and ease of use, and 4) confidence in measurement and perceived health empowerment. Reported as median (range) per dimension, and as an overall median score.
Proportion of Analyzable Recordings by Device
时间窗: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
For each device (NightOwl, SleepImage, Nox T3), the number of nights yielding an analyzable recording meeting predefined technical criteria, divided by the number of nights the device was worn, expressed as a percentage. The complementary proportion of failed, incomplete, or non-analyzable recordings is reported per device.
次要结局
- Additional Test Nights Required to Obtain Three Analyzable Nights(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 10 weeks after enrollment)
- Inclusion rate(Through study completion, an average of 1 year)
- Recruitment Source Distribution(Through study completion, an average of 1 year)
- Proportion of Participants Obtaining Three Nights With Analyzable Recordings(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 10 weeks after enrollment)
- Completeness of Baseline Assessments(Baseline (first visit).)
- Number of Test Night Attempts Before Participant Discontinuation(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 10 weeks after enrollment)
- Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 10 weeks after enrollment)
- Inclusion rate(Through study completion, an average of one month)
- Recruitment Source Distribution(Assessed after inclusion of the last participant)
- Proportion of Participants Obtaining Three Nights With Analyzable Recordings(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment)
- Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment)
- Number of Test Night Attempts Before Participant Discontinuation(Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment)
研究者
Preben Homøe
Professor
Zealand University Hospital