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

Overview

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 Title of Study: “Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 30, 2019

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

  • Other: Home Respiratory Polygraphy (HRP)
    • Randomizing to start with home respiratory polygraphy
  • Other: Standard Polysomnography (PSG)
    • Randomizing to start with Standard Polysomnography (PSG)
  • Other: Home Respiratory Polygraphy (HRP)
    • Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
  • Other: Standard Polysomnography (PSG)
    • Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Arms, Groups and Cohorts

  • Active Comparator: Diagnostic Randomizing
    • Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
  • Active Comparator: Therapeutic Randomizing
    • Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic validity of a Home Respiratory Polygraphy (HRP)
    • Time Frame: 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 Measures

  • Cost effectiveness analysis
    • Time Frame: 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).
  • Validation of the therapeutic decision
    • Time Frame: 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
    • Time Frame: 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.
    • Time Frame: 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
    • Time Frame: 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
  • Quality of life (KINDLR)
    • Time Frame: 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)
  • Children’s sleep habits questionnaire (CSHQ)
    • Time Frame: 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
    • Time Frame: baseline and at six month
    • Body mass index
  • Blood pressure
    • Time Frame: baseline and at six month
    • Blood pressure measurements: systolic blood pressure and diastolic blood pressure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Araba
  • Collaborator
    • Instituto de Salud Carlos III
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joaquin Duran-Cantolla, MD, Principal Investigator. MD,PhD – Hospital Universitario Araba

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