Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Obstructive sleep apnea syndrome (OSAS) in children
Brief summary
The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.
Detailed description
We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.
Interventions
DRUGPrednisolone and amoxicillin/clavulanate
Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
Sponsors
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Polysomnogram results showing mild obstructive sleep apnea.
Exclusion criteria
* Significant medical problems * Chronic medication intake (except bronchodilators and inhaled steroids) * Allergy to penicillin or its derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep apnea questionnaire | 1-2 weeks post treatment |
| Size of tonsils | before and after treatment |
Countries
United States
Outcome results
None listed