Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
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|ClinicalTrials.gov Identifier: NCT00936494|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : July 10, 2009
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Related Breathing Disorder Upper Airway Resistance Syndrome Obstructive Sleep Apnea||Procedure: Cold ablation inferior turbinate reduction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study)|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
No Intervention: Control
No inferior turbinate surgery.
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Procedure: Cold ablation inferior turbinate reduction
The procedure usually takes 30 minutes and involves the surgeon inserting the coblation inferior turbinate reduction wand into the inferior turbinates and allowing for the radiofrequency cold ablation to ablate soft tissues, with a resultant thermal lesion allowing for additional soft tissue attenuation and contracture with time.
- resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936494
|United States, Missouri|
|University Hospitals and Clinics|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Eliav Gov-Ari, MD||University of Missouri-Columbia|