Obstructive Sleep Apnea Clinical Trial
Official title:
Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study)
This study will examine whether treatment of inferior turbinates in patients with continued symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and adenoidectomy will improve these symptoms and should be included in the treatment paradigm for treatment of sleep related breathing disorders in infants, children, and adolescents.
The question proposed by this study is one of treatment: To what extent does treatment of
nasal obstruction from enlarged inferior turbinates with cold ablation inferior turbinate
reduction in infants, children, and adolescents improve symptoms of obstructive sleep apnea,
sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and
upper airway resistance syndrome in patients that continue to have symptoms after
tonsillectomy and adenoidectomy.
The trial seeks to provide evidence that the treatment of inferior turbinates in patients
with continued symptoms of obstructive sleep apnea, sleep related breathing disorder,
snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome
after tonsillectomy and adenoidectomy will improve these symptoms and should be included in
the treatment paradigm for treatment of sleep related breathing disorders in infants,
children, and adolescents.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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