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Completed

NCT Number: NCT06917768

Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

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.

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Key information

Conditions

Pediatric Obstructive Sleep Apnea

Age range

18 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu de France

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenotonsillectomy

Procedure

Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.

Other names: Coblation

Prednisolone

Drug

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 outcomes

  1. Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.

    Time frame: 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 outcomes

  1. Evaluate the evolution of symptoms' severity

    Time frame: 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).

  2. Evaluate tonsils' size evolution with treatment

    Time frame: 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.

  3. Evaluate potential treatment-related side effects

    Time frame: 6 months

    Evaluation of any potential treatment-related side effect through clinical interrogation at 1,3 and 6 months.

Sponsors and collaborators

Lead sponsor

Hotel Dieu de France Hospital

Other

Registry information

Official study title

Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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