Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00936494
First received: July 9, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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 ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Primary Completion Date: June 2010 (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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936494

Contacts
Contact: Young S Paik, MD 573-882-8173 paiky@health.missouri.edu
Contact: Eliav Gov-Ari, MD 573-882-8173 govarie@health.missouri.edu

Locations
United States, Missouri
University Hospitals and Clinics Recruiting
Columbia, Missouri, United States, 65212
Contact: Young Paik, MD       paiky@health.missouri.edu   
Contact: Eliav Gov-Ari, MD       govarie@health.missouri.edu   
Principal Investigator: Eliav Gov-Ari, MD         
Sub-Investigator: Young Paik, MD         
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Eliav Gov-Ari, M.D., Department of Otolaryngology-Head and Neck Surgery
ClinicalTrials.gov Identifier: NCT00936494     History of Changes
Other Study ID Numbers: 1137500
Study First Received: July 9, 2009
Last Updated: July 9, 2009
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:
Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014