Clinical Trial: Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study)
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University of Missouri-Columbia
Current Primary Outcome: resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Missouri-Columbia
Dates:
Date Received: July 9, 2009
Date Started: June 2009
Date Completion:
Last Updated: October 5, 2016
Last Verified: October 2016