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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Control; No inferior turbinate surgery.
Intervention; 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.; Other Names: Radiofrequency ablation surgery; CITR

Outcome Measures

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Primary Outcome Measures :

1. resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Missouri
University Hospitals and Clinics
Columbia, Missouri, United States, 65212

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

Principal Investigator:	Eliav Gov-Ari, MD	University of Missouri-Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00936494 History of Changes
Other Study ID Numbers:	1137500
First Posted:	July 10, 2009
Last Update Posted:	October 6, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of Missouri-Columbia:

obstructive sleep apnea; sleep related breathing disorder; snoring	disturbed sleeping; open mouth breathing; upper airway resistance syndrome

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Apnea; Respiration Disorders; Respiratory Tract Diseases	Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes