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Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS

NCT03169491 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-03-12

No results posted yet for this study

Summary

Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.

Conditions

  • Sleep Apnea, Obstructive
  • Child
  • Continuous Positive Airway Pressure
  • Adenoidectomy
  • Tonsillectomy

Interventions

DEVICE

Continuous positive airway pressure (CPAP)

CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed.

Sponsors & Collaborators

  • Instituto Nacional de Enfermedades Respiratorias

    lead OTHER_GOV

Principal Investigators

  • José Rogelio Pérez-Padilla, MD · Instituto Nacional Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-04
Primary Completion
2019-08-30
Completion
2019-11-30
FDA Device
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169491 on ClinicalTrials.gov