Status:
COMPLETED
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
Lead Sponsor:
Hospital Universitario Araba
Collaborating Sponsors:
Instituto de Salud Carlos III
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief 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...
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 sus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03449550
Start Date
May 7 2015
End Date
March 30 2020
Last Update
September 9 2021
Active Locations (1)
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1
Hospital Universitario Alava
Vitoria-Gasteiz, Alava, Spain, 01009