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

Hospital Universitario Araba

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: Standard Polysomnography (PSG); Other: Home Respiratory Polygraphy (HRP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03449550

PI14/01187

Details and patient eligibility

About

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).

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Diagnostic Randomizing

Active Comparator group

Description:

Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Treatment:

Other: Home Respiratory Polygraphy (HRP)

Other: Home Respiratory Polygraphy (HRP)

Other: Standard Polysomnography (PSG)

Other: Standard Polysomnography (PSG)

Therapeutic Randomizing

Active Comparator group

Description:

Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Treatment:

Other: Home Respiratory Polygraphy (HRP)

Other: Home Respiratory Polygraphy (HRP)

Other: Standard Polysomnography (PSG)

Other: Standard Polysomnography (PSG)