Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Change in Functional Outcomes of Sleep Questionnaire
研究概览
简要总结
This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.
详细描述
Individuals referred to the Sleep Disorder Centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. Using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the Prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). Other aspects of care including the clinical assessment will be equivalent between groups. A randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. Physicians participating in the study will receive an introduction to the Odds Ratio Product (ORP) and training on its diagnostic potential. Diagnostic confidence using a 5 point Likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review.
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
- 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
- •referral for major concern of "snoring" or "apnea" or "hypersomnia" with additional minor concerns of "snoring", "apneas" "restless leg syndrome" or "insomnia"
- •willing to undergo a sleep study
排除标准
- •referrals where parasomnias, respiratory failure, narcolepsy listed as concerns
- •comorbid congestive heart failure, ischemic heart disease, arrhythmia, stroke, chronic obstructive pulmonary disease/respiratory failure, patients with a BMI 50 kg/m2
- •undergone a previous sleep study
结局指标
主要结局
Change in Functional Outcomes of Sleep Questionnaire
时间窗: 4 months
Total Score scale ranges from 5-20, with higher scores representing better functioning
Rating of Physician Diagnostic Confidence
时间窗: within 4 weeks of sleep study, after patient assessment by physician
Likert scale rating performed by physicians to assess confidence in diagnosis from data provided by the two systems, scale from 1-5 with higher values reflecting greater confidence
Rating of Patient Satisfaction
时间窗: Measured in morning following their sleep study
Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction
Continuous Positive Airway Pressure (CPAP) Adherence
时间窗: 4 months
Percent of nights with CPAP \> 4 hours/night
Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees
时间窗: After study conclusion, an average of up to 1 year
Change in Calgary Sleep Apnea Quality of Life Index
时间窗: 4 months
Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life
Change in Epworth Sleepiness Scale
时间窗: 4 months
Scale ranges from 0-24, with higher scores representing more sleepiness
次要结局
未报告次要终点