Back to resultsInferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
Primary Purpose
Sleep Related Breathing Disorder, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold ablation inferior turbinate reduction
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Related Breathing Disorder focused on measuring obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, upper airway resistance syndrome
Eligibility 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.
Sites / Locations
- University Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Intervention
Arm Description
No inferior turbinate surgery.
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Outcomes
Primary Outcome Measures
resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire
Secondary Outcome Measures
Full Information
NCT ID
NCT00936494
First Posted
July 9, 2009
Last Updated
October 5, 2016
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00936494
Brief Title
Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
Official Title
Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Related Breathing Disorder, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, upper airway resistance syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No inferior turbinate surgery.
Arm Title
Intervention
Arm Type
Other
Arm Description
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Intervention Type
Procedure
Intervention Name(s)
Cold ablation inferior turbinate reduction
Other Intervention Name(s)
Radiofrequency ablation surgery, CITR
Intervention Description
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.
Primary Outcome Measure Information:
Title
resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliav Gov-Ari, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals and Clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
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