Pediatric Obstructive Sleep ApneaNCT06917768
Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea
A study testing Adenotonsillectomy and Prednisolone in people with Pediatric Obstructive Sleep Apnea, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 8 years
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea
- What is being tested?
- Adenotonsillectomy and Prednisolone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Dec 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children aged between 18 months and 8 years diagnosed with OSAS secondary to adenotonsillar hypertrophy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.
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.
- Conditions
- Pediatric Obstructive Sleep Apnea
- Being tested
- Adenotonsillectomy, Prednisolone
- Keywords
- Corticosteroids, Tonsillar hypertrophy, Pediatric OSA, Surgery, Coblation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenotonsillectomyProcedure or surgery
Also called Coblation
Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.
PrednisoloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgical treatment (adenotonsillectomy). | Active comparator | Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF. Receives: Procedure: Adenotonsillectomy |
| Patients undergoing medical treatment (short-term and low dose oral corticosteroids). | Experimental | 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. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 Dec 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is an interventional, prospective, non randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Majdalani, Hotel Dieu de France Hospital
- Investigators
- Simon J Rassi, Medical Doctor, Study director, Hotel Dieu de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917768
- Sponsor's protocol ID
- Tfem/2023/50
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fernandes RM, Wingert A, Vandermeer B, Featherstone R, Ali S, Plint AC, Stang AS, Rowe BH, Johnson DW, Allain D, Klassen TP, Hartling L. Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis. BMJ Open. 2019 Aug 1;9(8):e028511. doi: 10.1136/bmjopen-2018-028511.
PubMed 31375615Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
PubMed 16735907Meltzer LJ, Mindell JA. Sleep and sleep disorders in children and adolescents. Psychiatr Clin North Am. 2006 Dec;29(4):1059-76; abstract x. doi: 10.1016/j.psc.2006.08.004.
PubMed 17118282
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06917768
- Acronym / sponsor ID
- Tfem/2023/50
- Conditions
- Pediatric Obstructive Sleep Apnea
- Keywords
- Corticosteroids, Tonsillar hypertrophy, Pediatric OSA, Surgery, Coblation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is an interventional, prospective, non randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgical treatment (adenotonsillectomy). | Active comparator | Procedure: AdenotonsillectomyChildren undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF. |
| Patients undergoing medical treatment (short-term and low dose oral corticosteroids). | Experimental | Drug: PrednisoloneThe 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. |
Who may qualify
- Ages
- 18 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children aged between 18 months and 8 years diagnosed with OSAS secondary to adenotonsillar hypertrophy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenotonsillectomyAlso: CoblationChildren undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF. | Procedure or surgery | Patients undergoing surgical treatment (adenotonsillectomy). |
| PrednisoloneThe 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 | Patients undergoing medical treatment (short-term and low dose oral corticosteroids). |
Primary outcome
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.
3 secondary outcomes
Evaluate the evolution of symptoms' severity
Time frame: 6 months
Evaluate tonsils' size evolution with treatment
Time frame: 6 months
Evaluate potential treatment-related side effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Results publication: PubMed 31375615Fernandes RM, Wingert A, Vandermeer B, Featherstone R, Ali S, Plint AC, Stang AS, Rowe BH, Johnson DW, Allain D, Klassen TP, Hartling L. Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis. BMJ Open. 2019 Aug 1;9(8):e028511. doi: 10.1136/bmjopen-2018-028511.
- Results publication: PubMed 16735907Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
- Results publication: PubMed 17118282Meltzer LJ, Mindell JA. Sleep and sleep disorders in children and adolescents. Psychiatr Clin North Am. 2006 Dec;29(4):1059-76; abstract x. doi: 10.1016/j.psc.2006.08.004.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon J Rassi, Medical Doctor study director
Hotel Dieu de France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenotonsillectomy and Prednisolone in people with Pediatric Obstructive Sleep Apnea, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.