Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Pediatric Obstructive Sleep Apnea
• Interventions: Procedure: Adenotonsillectomy; Drug: Prednisolone

• Registration Number: NCT06917768
• Lead Sponsor: Hotel Dieu de France Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• All children aged between 18 months and 8 years diagnosed with OSAS secondary to adenotonsillar hypertrophy

Exclusion Criteria

• Children under 18 months or over 8 years old
• History of acute or chronic cardiorespiratory neuromuscular, or metabolic diseases
• Congenital craniofacial anomalies
• Chromosomal disorders
• Epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients undergoing surgical treatment (adenotonsillectomy).	Adenotonsillectomy	Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.
Patients undergoing medical treatment (short-term and low dose oral corticosteroids).	Prednisolone	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.

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate tonsils' size evolution with treatment	6 months	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.
Evaluate potential treatment-related side effects	6 months	Evaluation of any potential treatment-related side effect through clinical interrogation at 1,3 and 6 months.
Evaluate the evolution of symptoms' severity	6 months	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).

Trial Locations

Locations (1)

Hotel Dieu de France; 🇱🇧 Beirut, Lebanon