Clinical trial NCT03449550: Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
Official title: Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Child obstructive sleep apnea
Home Respiratory Polygraphy
Diagnosis
Validity
Polysomnography
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: ResMed
name: Complejo Hospitalario de Caceres
name: Hospital Universitario de Burgos
name: Hospital Universitario Marqués de Valdecilla
name: Hospital de Basurto
name: Hospital Vall d'Hebron
name: Fundación Jimenez Diaz de Madrid
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
name: Hospital Clínico Universitario de Valladolid
name: Hospital de Guadalajara
name: University of Chicago
First posted: 2018-02-28
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic validity of a Home Respiratory Polygraphy (HRP)
timeFrame: baseline
Secondary outcomes:
measure: Cost effectiveness analysis
timeFrame: baseline
measure: Validation of the therapeutic decision
timeFrame: 6 month
measure: Validity of the determination of a protein sequence in urine in OSA
timeFrame: baseline
measure: Pediatric Sleep Questionnaire.
timeFrame: baseline and at six month
measure: BEARS Sleep screening
timeFrame: baseline and at six month
measure: Quality of life (KINDLR)
timeFrame: baseline and at six month
measure: Children's sleep habits questionnaire (CSHQ)
timeFrame: baseline and at six month
measure: Anthropometric variables
timeFrame: baseline and at six month
measure: Blood pressure
timeFrame: baseline and at six month
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Hospital Universitario Alava
state: Alava
Study officials:
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