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Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing

University of Missouri (MU) logo

University of Missouri (MU)

Status

Terminated

Conditions

Upper Airway Resistance Syndrome
Sleep Related Breathing Disorder
Obstructive Sleep Apnea

Treatments

Procedure: Cold ablation inferior turbinate reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT00936494
1137500

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

Control
No Intervention group
Description:
No inferior turbinate surgery.
Intervention
Other group
Description:
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Treatment:
Procedure: Cold ablation inferior turbinate reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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