Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).
详细描述
To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA).
METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Cost-effectiveness variables.
ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the Receiver Operating Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years to 75 years old, with clinical suspicion of OSA
- •Written informed consent signed
排除标准
- •Psycho-Physical inability to perform the study at home
- •Presence of insomnia or depressive syndrome
- •Patient with malformation syndromes, Down syndrome and neuromuscular diseases
- •Cardiovascular, cerebrovascular or respiratory disease exacerbated.
- •Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA
研究组 & 干预措施
Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
干预措施: Home Respiratory Polygraphy (APNIA) (Other)
Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
干预措施: Standard Polysomnography (PSG) (Other)
Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
干预措施: Home Respiratory Polygraphy (APNIA) (Other)
Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
干预措施: Standard Polysomnography (PSG) (Other)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: baseline
To assess the diagnostic validity of a home respiratory polygraphy (HRP) compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI).
次要结局
- Therapeutic decision(6 month)
- STOP-BANG Sleep apnea questionnaire(baseline and at 6 month)
- Blood pressure(baseline and at 6 month)
- Epworth Sleepiness Scale(baseline and at 6 month)
- Cost-effectiveness analysis(6 month)
- Anthropometric variables (Body mass index)(baseline and at 6 month)
- Berlin questionnaire(baseline and at 6 month)
- Quality of life (EuroQOL test)(baseline and at 6 month)
研究者
Joaquin Duran-Cantolla, MD
Principal Investigator. MD, PhD
Hospital Universitario Araba