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Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS) — DINISAS  

Obstructive Sleep Apnea Clinical Trial

Official title:
Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03449550
Study type Interventional
Source Hospital Universitario Araba
Contact
Status Completed
Phase N/A
Start date May 7, 2015
Completion date March 30, 2020
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