Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Diagnostic validity of a Home Respiratory Polygraphy (HRP)
研究概览
简要总结
To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).
详细描述
AIMS: To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).
METHODOLOGY: DESIGN: Randomized, prospective, multicenter, double blind and crossover trial. The study will include 320 children, 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) clinic history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c) Chervin questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Quantitative unbiased proteinic urine analysis and g) 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 ROC curves; 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 by participating hospitals according the Cohen Kappa method, 4) A diagnosis paradigm based on proteinic defined variables and 5) 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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
- •Written informed consent signed.
排除标准
- •Place of residence more than 100 km from the hospital
- •Psychophysical incapacity to perform the study at home
- •Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
- •Children with chronic insomnia and / or depressive syndrome
- •Children with malformative syndromes, Down Syndrome and neuromuscular diseases
- •Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP
- •History of surgery and / or previous Positive continuous pressure (CPAP) for OSA
结局指标
主要结局
Diagnostic validity of a Home Respiratory Polygraphy (HRP)
时间窗: baseline
To establish the diagnostic validity of home respiratory polygraphy (HRP) compared with the findings obtained with polysomnography (PSG) in the sleep laboratory in children with suspected Obstructive Sleep Apnea (OSA), based on the results of Apnea-hypopnea Index (AHI)
次要结局
- Cost effectiveness analysis(baseline)
- Validation of the therapeutic decision(6 month)
- BEARS Sleep screening(baseline and at six month)
- Validity of the determination of a protein sequence in urine in OSA(baseline)
- Pediatric Sleep Questionnaire.(baseline and at six month)
- Quality of life (KINDLR)(baseline and at six month)
- Anthropometric variables(baseline and at six month)
- Children's sleep habits questionnaire (CSHQ)(baseline and at six month)
- Blood pressure(baseline and at six month)
研究者
Joaquin Duran-Cantolla, MD
Principal Investigator. MD,PhD
Hospital Universitario Araba