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Maxillary Expansion Treatment of Pediatric OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Benjamin Pliska, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Maxillary expansion Procedure: Adenotonsillectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Maxillary expansion as First treatment
Orthodontic expansion of upper jaw, then cross-over to adenotonsillectomy
Procedure: Maxillary expansion
Procedure: Adenotonsillectomy
Active Comparator: Adenotonsillectomy as First treatment
surgical removal of tonsils and adenoids, then cross-over to maxillary expansion
Procedure: Maxillary expansion
Procedure: Adenotonsillectomy



Primary Outcome Measures :
  1. apnea-hypopnea index [ Time Frame: 4 months after intervention ]
    Polysomnography sleep test score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Julie Pauwels, MHA 6048752000 ext 5189 julie.pauwels@cw.bc.ca

Locations
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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    julie.pauwels@cw.bc.ca   
Principal Investigator: Benjamin T Pliska, DDS MS         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Benjamin Pliska, DDS University of British Columbia
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Responsible Party: Benjamin Pliska, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01837914    
Other Study ID Numbers: H12-02721
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NA no IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases