Study Stopped
Lack of enrollment
Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 6, 2016
October 1, 2016
1.9 years
July 9, 2009
October 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
resolution of obstructive sleep apnea symptoms on pediatric sleep questionaire
6 months
Study Arms (2)
Control
NO INTERVENTIONNo inferior turbinate surgery.
Intervention
OTHERIntervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals and Clinics
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliav Gov-Ari, MD
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 10, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
October 6, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share