Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 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 an infrared thermography system in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).
详细描述
AIMS: To assess the diagnostic validity and cost-effectiveness of an infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and identify respiratory events, compared to conventional polysomnography (PSG) in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).
METODOLOGY: DESIGN: Prospective, unicentric, randomized and blinded study carried out into two phases: Phase I: Development of the tool in 99 full valuable adults with suspected OSA (PSG recruitment, coordination and quality control, image capture, Information and development of the expert system); Phase II: Validation of the tool compared with the PSG in another group of 99 full valuable adults with suspected OSA. INSTRUMENTALIZATION: a) Clinical history and anthropometric variables; b) Sleep and quality of life questionnaires; c) PSG; d) TIS; e) Cost-effectiveness study.
ANALYSYS : The validity of the results of the TIS will be analyzed compared with the results of the PSG. The agreement measure will be established according to the different categories of the Apnea-Hypopnea Index (AHI), using ROC (Receiver Operating Characteristic) curves and the area under the curve. The investigators will also validate the therapeutic decisions made with PSG compared to those performed with the TIS. Finally, a cost-effectiveness study will be performed.
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 (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
- •Place of residence more than 100 km from the hospital
- •Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
- •Presence of insomnia, depressive syndrome or epilepsia
- •Patients diagnosed of any acute inflammatory episode of the cranium-maxillo-facial area or any systemic infection that develops with fever> 38 ºC at the time of testing
- •Patient with malformation syndromes, Down syndrome and neuromuscular diseases
- •Patient on active treatment with Positive continuous pressure (CPAP )
研究组 & 干预措施
Infrared thermography system
Therapeutic decision taken with infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and Apnea-Hypopnea Index (AHI).
干预措施: Therapeutic decision Infrared thermgraphy system (Other)
Standard Polysomnography (PSG)
Therapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI)
干预措施: Therapeutic decision PSG (Other)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: Baseline
Count the respiratory events (apneas and hypopneas) that occur during sleep using a high sensitivity infrared thermal camera integrated in an expert diagnostic algorithm (TIS).
次要结局
- Anthropometric variables (Body mass index)(baseline and at 6 month)
- Validation of the therapeutic decision(6 month)
- Blood pressure(baseline and at 6 month)
- Quality of life (EuroQOL test)(baseline and at 6 month)
- Epworth Sleepiness Scale(baseline and at 6 month)
- Cost effectiveness analysis(6 month)
- STOP-Bang Questionnaire(baseline and at 6 month)
- Berlin questionnaire(baseline and at 6 month)
研究者
Carlos Javier Egea Santaolalla,Ph
Principal Investigator, MD, PhD
Hospital Universitario Araba