Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
NCT ID: NCT03449550
Last Updated: 2021-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2015-05-07
2020-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
Home Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
Home Respiratory Polygraphy (HRP)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Interventions
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Home Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Home Respiratory Polygraphy (HRP)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent signed.
Exclusion Criteria
* 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
2 Years
14 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
ResMed
INDUSTRY
Complejo Hospitalario de Caceres
OTHER
Hospital Universitario de Burgos
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital de Basurto
OTHER
Hospital Vall d'Hebron
OTHER
Fundación Jimenez Diaz de Madrid
UNKNOWN
Hospital Universitario La Paz
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Hospital de Guadalajara
UNKNOWN
University of Chicago
OTHER
Hospital Universitario Araba
OTHER
Responsible Party
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Joaquin Duran-Cantolla, MD
Principal Investigator. MD,PhD
Locations
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Hospital Universitario Alava
Vitoria-Gasteiz, Alava, Spain
Countries
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References
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Other Identifiers
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PI14/01187
Identifier Type: -
Identifier Source: org_study_id
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