An interventional study of Adenotonsillectomy and Prednisolone in Pediatric Obstructive Sleep Apnea, sponsored by Hotel Dieu de France Hospital. Completed at 1 site in Lebanon. Open to participants aged 18 Months to 8 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Hotel Dieu de France Hospital · Not applicable, Interventional, and Treatment
This prospective interventional clinical trial (non-randomized) aims to evaluate oral corticosteroids' role as an alternative to surgery (gold-standard) in the treatment of obstructive sleep apnea in children. It also evaluates the evolution of symptoms' severity as well as any side effects linked to treatment.
This prospective study included children aged between 18 months and 8 years who consulted the same pediatric ENT physician's clinic for OSA secondary to adenotonsillar hypertrophy with no other comorbidities. They were divided into 2 Groups. Children undergoing intracapsular adenotonsillectomy by Coblation™ (Group 1) were compared to those receiving oral prednisolone at a dose of 1mg/kg for 5 days and 1 month of intranasal corticosteroids (Group 2). The follow-up tools were the Pediatric Sleep Questionnaire (PSQ) score and the size of the tonsils (Brodsky classification) evaluated at 1, 3 and 6 months.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 87 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Hotel Dieu de France Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.
Procedure: Adenotonsillectomy
The second Group includes children whose parents have refused surgery despite informed understanding of the therapeutic algorithm of OSA. They received medical treatment consisting of a 1-month treatment with intranasal corticosteroids, coupled with a 5-day course of oral corticosteroids (prednisolone) at a safe dose of 1mg/kg.
Drug: Prednisolone
Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.
Also known as: Coblation
The second Group includes children whose parents have refused surgery despite informed understanding of the therapeutic algorithm of OSA. They received medical treatment consisting of a 1-month treatment with intranasal corticosteroids, coupled with a 5-day course of oral corticosteroids (prednisolone) at a safe dose of 1mg/kg.
Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.
In Group 2, failure of medical treatment is defined by a persistence of apnea assessed by the clinician and parents and therefore a need for surgery within 6 months of follow-up, while therapeutic success reflects an improvement in symptoms and a disappearance of apnea documented by video, and therefore the absence of need for surgery after 6 months of follow-up.
Time frame: 6 months
Evaluate the evolution of symptoms' severity
Evaluation at 1, 3 and 6 months of treatment (or surgery) the evolution of the OSA-related symptoms through the Pediatric Sleep Questionnaire. The Pediatric Sleep Questionnaire consists of 22 questions related to Pediatric OSA. The score is graded from 0 to 22 and is proportional to symptoms' severity (a higher score means a more severe sleep apnea).
Time frame: 6 months
Evaluate tonsils' size evolution with treatment
Evaluation at 1, 3 and 6 months of the evolution of tonsils' size through clinical evaluation using the Brodsky Score for tonsil size evaluation. Brodsky score can be 0, 1, 2, 3 or 4. A higher score reflects bigger tonsils.
Time frame: 6 months
Evaluate potential treatment-related side effects
Evaluation of any potential treatment-related side effect through clinical interrogation at 1,3 and 6 months.
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Hotel Dieu de France Hospital