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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
320
Randomizing to start with home respiratory polygraphy
Randomizing to start with Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Hospital Universitario Alava
Vitoria-Gasteiz, Alava, Spain
Diagnostic validity of a Home Respiratory Polygraphy (HRP)
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)
Time frame: baseline
Cost effectiveness analysis
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).
Time frame: baseline
Validation of the therapeutic decision
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)
Time frame: 6 month
Validity of the determination of a protein sequence in urine in OSA
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
Time frame: baseline
Pediatric Sleep Questionnaire.
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 disorder
Time frame: baseline and at six month
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Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
BEARS Sleep screening
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
Time frame: baseline and at six month
Quality of life (KINDLR)
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)
Time frame: baseline and at six month
Children's sleep habits questionnaire (CSHQ)
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.
Time frame: baseline and at six month
Anthropometric variables
Body mass index
Time frame: baseline and at six month
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
Time frame: baseline and at six month