MedTrace Logo

Maxillary Expansion Treatment of Pediatric OSA

NCT01837914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-11-22

No results posted yet for this study

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 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.

Conditions

Interventions

PROCEDURE

Maxillary expansion

PROCEDURE

Adenotonsillectomy

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Benjamin Pliska, DDS · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837914 on ClinicalTrials.gov