Obstructive Sleep Apnea
Conditions
Keywords
Child obstructive sleep apnea, Home Respiratory Polygraphy, Diagnosis, Validity, Polysomnography
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.
Interventions
OTHERHome Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
Randomizing to start with Standard Polysomnography (PSG)
Sponsors
Instituto de Salud Carlos III
ResMed
Complejo Hospitalario de Caceres
Hospital Universitario de Burgos
Hospital Universitario Marqués de Valdecilla
Hospital de Basurto
Hospital Vall d'Hebron
Fundación Jimenez Diaz de Madrid
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Hospital Clínico Universitario de Valladolid
Hospital de Guadalajara
University of Chicago
Hospital Universitario Araba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 disorder |
| 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 |
| 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). |
| 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. |
| Anthropometric variables | baseline and at six month | Body mass index |
| Blood pressure | baseline and at six month | Blood pressure measurements: systolic blood pressure and diastolic blood pressure |
| Quality 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) |
Countries
Spain
Outcome results
None listed