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Clinical Trials/TCTR20230824001
TCTR20230824001
Recruiting
Phase 3

A Randomized Controlled Trial Comparing Treatment Efficacy Between Rapid Palatal Expansion and Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Pilot Study

ational Research Council of Thailand (NRCT)0 sites24 target enrollmentAugust 24, 2023

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pediatric obstructive sleep apnea (POSA)
Sponsor
ational Research Council of Thailand (NRCT)
Enrollment
24
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 24, 2023
End Date
May 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Research Council of Thailand (NRCT)

Eligibility Criteria

Inclusion Criteria

  • 1\.Patient has signs and symptoms of pediatric sleep apnea
  • 2\.Patient has a pediatric OSA diagnosis confirmed by an overnight Type I polysomnography.
  • 3\.Patient presents with adenotonsillar hypertrophy grade 2 or more based on clinical evaluation by a board certified ENT specialist.
  • 4\.Patient presents with narrow and constricted maxilla with or without posterior dental crossbite, diagnosed clinically by a board certified orthodontist.
  • 5\.Patient is between 4 to 10 years of age.

Exclusion Criteria

  • Presence of other significant pathologies, such as all craniofacial syndromes that could influence upper airway patency including cleft lip and palate, significant sagittal relationship (severe maxilla or mandible hypoplasia), severe obesity and past medical history that could prevent patients from undergoing adenotonsillectomy i.e. severe heart disease and diabetes mellitus.

Outcomes

Primary Outcomes

Not specified

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