Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing
This study has been terminated.
(Lack of enrollment)
Sponsor:
University of Missouri-Columbia
Information provided by (Responsible Party):
Eliav Gov-Ari, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00936494
First received: July 9, 2009
Last updated: October 28, 2015
Last verified: October 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Related Breathing Disorder Upper Airway Resistance Syndrome Obstructive Sleep Apnea |
Procedure: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR). |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study) |
Resource links provided by NLM:
Further study details as provided by University of Missouri-Columbia:
Primary Outcome Measures:
- resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 2 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 utilizing radiofrequency ablation surgery (CITR).
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.
|
Eligibility| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
- Enlarged inferior turbinates with nasal obstruction (>25%).
- Age 0-18 years.
- 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:
- Previous adenotonsillar surgery or placement of tympanostomy tubes for recurrent otitis media, tonsillitis, or sinusitis.
- Patients with BMI > 97% for age and sex.
- Patients with craniofacial abnormalities.
- 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00936494
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936494
Locations
| United States, Missouri | |
| University Hospitals and Clinics | |
| Columbia, Missouri, United States, 65212 | |
Sponsors and Collaborators
University of Missouri-Columbia
More Information
| Responsible Party: | Eliav Gov-Ari, Principal Investigator, University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00936494 History of Changes |
| Other Study ID Numbers: | 1137500 |
| Study First Received: | July 9, 2009 |
| Last Updated: | October 28, 2015 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016