Maxillary Expansion Treatment of Pediatric OSA

NCT01837914 | Completed

• 1 other identifier: H12-02721
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• apnea-hypopnea index

  Polysomnography sleep test score

  4 months after intervention

Study Arms (2)

Maxillary expansion as First treatment

EXPERIMENTAL

Orthodontic expansion of upper jaw, then cross-over to adenotonsillectomy

Procedure: Maxillary expansion; Procedure: Adenotonsillectomy

Adenotonsillectomy as First treatment

ACTIVE COMPARATOR

surgical removal of tonsils and adenoids, then cross-over to maxillary expansion

Procedure: Maxillary expansion; Procedure: Adenotonsillectomy

Interventions

Maxillary expansion PROCEDURE

Adenotonsillectomy as First treatment; Maxillary expansion as First treatment

Adenotonsillectomy PROCEDURE

Adenotonsillectomy as First treatment; Maxillary expansion as First treatment

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital Otolaryngology Department

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• Benjamin Pliska, DDS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)