Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Other: Home Respiratory Polygraphy (HRP)Other: Standard Polysomnography (PSG)
- Registration Number
- NCT03449550
- Lead Sponsor
- Hospital Universitario Araba
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Diagnostic Randomizing Home Respiratory Polygraphy (HRP) Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG) Therapeutic Randomizing Home Respiratory Polygraphy (HRP) Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG) Diagnostic Randomizing Standard Polysomnography (PSG) Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG) Therapeutic Randomizing Standard Polysomnography (PSG) Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
- Primary Outcome Measures
Name Time Method Diagnostic validity of a Home Respiratory Polygraphy (HRP) 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)
- Secondary Outcome Measures
Name Time Method Cost effectiveness analysis baseline Cost-efficacy evaluation: the analysis will be made in both arms based on intention to treat. Only direct costs will be analyzed: the cost of the use of polysomnography and home respiratory polygraphy (Staff and consumable material).
Validation of the therapeutic decision 6 month Analyze the concordance in the therapeutic decision using clinical findings and the results of Apnea-Hypopnea Index (AHI) from standard polysomnography (PSG) compared with data from home respiratory polygraphy (HRP)
BEARS Sleep screening baseline and at six month BEARS Sleep screening is divided into five major sleep domains (B=Bedtime Issues, E=Excessive Daytime Sleepiness, A=Night Awakenings, R=Regularity and Duration of Sleep, S=Snoring), providing a comprehensive screen for the major sleep disorders affecting children in the 2- to 18-year old range
Validity of the determination of a protein sequence in urine in OSA baseline To analyze the validity of the determination of a protein sequence in urine, alone or in combination, to establish the diagnosis of OSA and to evaluate its modification over time after the treatment of OSA
Pediatric Sleep Questionnaire. baseline and at six month Pediatric Sleep Questionnaire designed to screen for sleep problems in children.The scale consists of 22 parent-reported items examining snoring and breathing problems, daytime sleepiness, inattention, hyperactivity, and other signs and symptoms of apnea including obesity and nocturnal enuresis.
The result is a number, a proportion that ranges from 0.0 to 1.0. Scores \>0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorderQuality of life (KINDLR) baseline and at six month The KINDLR is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3 years and older. Consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school). The response categories cover 3 levels (1=never, 2=sometimes, 3=very often)
Anthropometric variables baseline and at six month Body mass index
Children's sleep habits questionnaire (CSHQ) baseline and at six month Parent-report sleep screening instrument designed for school-aged children.The instrument evaluates the child's sleep based on behavior within eight different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness.
Blood pressure baseline and at six month Blood pressure measurements: systolic blood pressure and diastolic blood pressure
Trial Locations
- Locations (1)
Hospital Universitario Alava
🇪🇸Vitoria-gasteiz, Alava, Spain