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

September 8, 2021 updated by: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria-gasteiz, Alava, Spain, 01009
        • Hospital Universitario Alava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
Other: Home Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
Other Names:
  • Validity
Other: Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Other Names:
  • Validity
Other: Home Respiratory Polygraphy (HRP)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Other Names:
  • Effectiveness
Other: Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Names:
  • Effectiveness
Active Comparator: Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
Other: Home Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
Other Names:
  • Validity
Other: Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Other Names:
  • Validity
Other: Home Respiratory Polygraphy (HRP)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Other Names:
  • Effectiveness
Other: Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Names:
  • Effectiveness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline
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)
6 month
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
baseline
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
baseline and at six month
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
baseline and at six month
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)
baseline and at six month
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.
baseline and at six month
Anthropometric variables
Time Frame: baseline and at six month
Body mass index
baseline and at six month
Blood pressure
Time Frame: baseline and at six month
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
baseline and at six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Araba

Collaborators

University of Chicago
ResMed
Hospital de Basurto
Instituto de Salud Carlos III
Hospital Universitario 12 de Octubre
Hospital Universitario La Paz
Hospital Vall d'Hebron
Hospital Universitario Marqués de Valdecilla
Hospital Clínico Universitario de Valladolid
Hospital Universitario de Burgos
Complejo Hospitalario de Caceres
Fundación Jimenez Diaz de Madrid
Hospital de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2015

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI14/01187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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