Maxillary Expansion Treatment of Pediatric OSA
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|ClinicalTrials.gov Identifier: NCT01837914|
Recruitment Status : Unknown
Verified June 2017 by Benjamin Pliska, University of British Columbia.
Recruitment status was: Recruiting
First Posted : April 23, 2013
Last Update Posted : June 26, 2017
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 jaws. This prospective, randomized cross-over study will evaluate the effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the current standard of care which is surgical removal of the adenoids and tonsils.
Patients will be evaluated by both an orthodontist and ENT physician, complete a series of questionnaires and undergo an overnight sleep study, both initially and after undergoing the randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea will then be crossed over and receive the other form of treatment. The levels of improvement to both subjective (questionnaire) and objective (overnight sleep study) measures of sleep apnea will then be compared.
The null hypothesis is there is no significant difference in improvement between maxillary expansion and adenotonsillectomy in the objective and subjective outcome measures in children with mild to moderate obstructive sleep apnea.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Procedure: Maxillary expansion Procedure: Adenotonsillectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Maxillary Expansion Treatment of Pediatric Obstructive Sleep Apnea|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Maxillary expansion as First treatment
Orthodontic expansion of upper jaw, then cross-over to adenotonsillectomy
Procedure: Maxillary expansion
Active Comparator: Adenotonsillectomy as First treatment
surgical removal of tonsils and adenoids, then cross-over to maxillary expansion
Procedure: Maxillary expansion
- apnea-hypopnea index [ Time Frame: 4 months after intervention ]Polysomnography sleep test score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837914
|Contact: Julie Pauwels, MHA||6048752000 ext firstname.lastname@example.org|
|Canada, British Columbia|
|BC Children's Hospital Otolaryngology Department||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: Julie Pauwels, MHA 604-875-2000 ext 5189 email@example.com|
|Principal Investigator: Benjamin T Pliska, DDS MS|
|Principal Investigator:||Benjamin Pliska, DDS||University of British Columbia|