Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing

Not Applicable

Terminated

• Conditions: Upper Airway Resistance Syndrome; Sleep Related Breathing Disorder; Obstructive Sleep Apnea
• Interventions: Procedure: Cold ablation inferior turbinate reduction

• Registration Number: NCT00936494
• Lead Sponsor: University of Missouri-Columbia

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 Description

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Patients that underwent tonsillectomy and adenoidectomy for obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome with persistent symptomatology.
2. Enlarged inferior turbinates with nasal obstruction (>25%).
3. Age 0-18 years.
4. Lack of improvement of obstructive sleep apnea symptoms after maximal medical treatment with intranasal steroids in patients with symptoms of ARS and H2 blocker medication in patients with symptoms of LPR.

Exclusion Criteria

1. Previous adenotonsillar surgery or placement of tympanostomy tubes for recurrent otitis media, tonsillitis, or sinusitis.
2. Patients with BMI > 97% for age and sex.
3. Patients with craniofacial abnormalities.
4. Patients with previous airway issues, anatomic variance from normal, mallampati class III or IV, septal deviation, choanal stenosis, and nasal stenosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cold ablation inferior turbinate reduction	Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).

Primary Outcome Measures

Name	Time	Method
resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire	6 months

Trial Locations

Locations (1)

University Hospitals and Clinics; 🇺🇸 Columbia, Missouri, United States