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

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).

Conditions

• Obstructive Sleep Apnea

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)

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• ResMed

  collaborator INDUSTRY

• Complejo Hospitalario de Caceres

  collaborator OTHER

• Hospital Universitario de Burgos

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital de Basurto

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Fundación Jimenez Diaz de Madrid

  collaborator UNKNOWN

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital de Guadalajara

  collaborator UNKNOWN

• University of Chicago

  collaborator OTHER

• Hospital Universitario Araba

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

2 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-07

Primary Completion

2019-04-30

Completion

2020-03-30

Countries

• Spain

Study Locations