Status:
COMPLETED
Maxillary Expansion Treatment of Pediatric OSA
Lead Sponsor:
University of British Columbia
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of children. The disease is believed to have several overlapping causes including large tonsils and small or narrow j...
Detailed Description
Background Literature Review Obstructive sleep apnea syndrome (OSAS) is a sleep disorder characterized by recurrent, partial or complete episodes of upper airway obstruction, commonly associated with ...
Eligibility Criteria
Inclusion
- Ages 6.0 to 10.0 years at the time of screening;
- Diagnosed with obstructive sleep apnea defined as AHI\>2, confirmed on overnight, laboratory-based PSG;
- Parental report of witnessed apneas or habitual snoring (on average more than 3 nights per week);
- Deemed to be a candidate for ME by orthodontic evaluation;
- Deemed to be a candidate for tonsillectomy and adenoidectomy by otolaryngologic evaluation.
Exclusion
- Severe OSA or significant hypoxemia in the presence of tonsillar or adenoid hypertrophy requiring surgical intervention defined as AHI\>25 or SpO2 \<90% for \>2% sleep time.
- An associated craniofacial syndrome or anomaly, including cleft lip and/or palate, or any anatomic or systemic condition that would otherwise exclude the patient from orthodontic treatment.
- Recurrent tonsillitis that meets American Academy of Otolaryngology - Head and Neck Surgery clinical practice guidelines for surgery.
- Extremely overweight defined as a body mass index z-score \> 2.99 for age group and sex.
- Severe health problems that could be exacerbated by delayed treatment for OSA, including: severe cardiopulmonary disorders (e.g., cystic fibrosis, congenital heart disease); sickle cell disease; poorly controlled asthma (with \> 1 hospitalization in last year); epilepsy requiring medication; diabetes (type 1 or type 2) requiring medication; doctor-diagnosed heart disease; or a history of stage II hypertension (HTN) defined as \> 99% percentile and/or requiring medication.
- Psychiatric or behavioral disorders that would otherwise exclude the patient from receiving orthodontic treatment
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01837914
Start Date
May 1 2013
End Date
December 1 2018
Last Update
November 22 2022
Active Locations (1)
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1
BC Children's Hospital Otolaryngology Department
Vancouver, British Columbia, Canada, V6H 3N1