Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
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| ClinicalTrials.gov Identifier: NCT00936494 |
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Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : July 10, 2009
Last Update Posted : October 6, 2016
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| 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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control
No inferior turbinate surgery.
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Intervention
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
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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:
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- resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire [ Time Frame: 6 months ]
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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 |
| Responsible Party: | University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00936494 History of Changes |
| Other Study ID Numbers: |
1137500 |
| First Posted: | July 10, 2009 Key Record Dates |
| 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:
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obstructive sleep apnea sleep related breathing disorder snoring |
disturbed sleeping open mouth breathing upper airway resistance syndrome |
Additional relevant MeSH terms:
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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 |