CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
Home Respiratory Polygraphy (HRP) +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03449550
NCT03449550N/ACompleted
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Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

Hospital Universitario Araba·interventional·Posted Feb 28, 2018·Updated Sep 9, 2021

In Brief

A clinical study evaluating Home Respiratory Polygraphy (HRP) and Standard Polysomnography (PSG) for Obstructive Sleep Apnea. Completed, enrolled 320 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesSpain
CollaboratorsInstituto de Salud Carlos III, ResMed, Complejo Hospitalario de Caceres, Hospital Universitario de Burgos, Hospital Universitario Marqués de Valdecilla, Hospital de Basurto, Hospital Vall d'Hebron, Fundación Jimenez Diaz de Madrid, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital Clínico Universitario de Valladolid, University of Guadalajara, University of Chicago

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartMay 7, 2015
Primary CompletionApr 30, 2019
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 8.3 years ago

Interventions

Home Respiratory Polygraphy (HRP)other

Randomizing to start with home respiratory polygraphy

Standard Polysomnography (PSG)other

Randomizing to start with Standard Polysomnography (PSG)

Home Respiratory Polygraphy (HRP)other

Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)

Standard Polysomnography (PSG)other

Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)