- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05638087
Dexamethasone Treatment for OSA in Children
Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas.
The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects.
Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown.
The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial.
Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mystica Terrance, BSc
- Phone Number: 6479261307
- Email: mystica.terrance@sickkids.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5V 1X8
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Mystica Terrance, BSc
- Email: mystica.terrance@sickkids.ca
-
Principal Investigator:
- Indra Narang, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)
- Aged 2-10 years
- Presence of adenotonsillar hypertrophy
- Ability to take oral medication and be willing to adhere to the dosing regimen
- Informed consent provided in accordance with institutional policies
Exclusion Criteria:
- Previous adenotonsillectomy
- Presence of symptoms of an upper respiratory tract infection
- Co-existing central sleep apnea
- Hypertension
- Prior or current evidence for abnormal glucose tolerance
- Contraindication for dexamethasone or components of dexamethasone oral suspension,
- Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention
- OSA with associated oxygen desaturations <90% for 2 continuous minutes
- Need for non-invasive ventilation long-term due to underlying disease
- Current systemic fungal infections
- Patients with clinically relevant varicella exposure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexamethasone Treatment
Oral Dexamethasone treatment
|
Dexamethasone Oral Suspension
|
Placebo Comparator: Placebo Treatment
Placebo control
|
Placebo Oral Mix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obstructive apnea-hypopnea index
Time Frame: Baseline and 2-4 weeks
|
Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr |
Baseline and 2-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Time Frame: Baseline and 2-4 weeks
|
Total CSHQ score of 41 has been reported to be a sensitive clinical cut-off point for detecting possible sleep problems
|
Baseline and 2-4 weeks
|
Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline and 2-4 weeks
|
The SDQ is a validated parent-reported behavioural screening questionnaire and is used to assess children's mental health.
The total difficulties score ranges from 0 to 40, a higher score indicates higher difficulties.
|
Baseline and 2-4 weeks
|
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
Time Frame: Baseline and 2-4 weeks
|
The OSA-18 QoL survey is a validated 18-item quality of life measure for children with sleep-disordered breathing (SDB) for children 2-18.
Higher total scores indicate more impact on QoL - minor impact (scores below 60), moderate impact (scores between 60 and 80) and major impact (scores above 80).
|
Baseline and 2-4 weeks
|
Soft tissue size (Adenoids, Tonsils & Turbinates)
Time Frame: Baseline and 2-4 weeks
|
Change in soft tissue size (adenoids, tonsils and turbinates) from baseline
|
Baseline and 2-4 weeks
|
Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline
Time Frame: At baseline
|
Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA
|
At baseline
|
Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)
Time Frame: At baseline
|
Cells from nasal brushing will be cultured and harvested for RNA to study gene expression.
|
At baseline
|
Participant recruitment rate
Time Frame: From study start to completion; up to 6 months
|
Feasibility determined by participant recruitment rate
|
From study start to completion; up to 6 months
|
Participant retention rate
Time Frame: From study start to completion; up to 6 months
|
Feasibility determined by participant retention rate
|
From study start to completion; up to 6 months
|
Participant adherence rate
Time Frame: From study start to completion; up to 6 months
|
Feasibility determined by participant adherence rate
|
From study start to completion; up to 6 months
|
Adverse events
Time Frame: From study start to completion; up to 6 months
|
Safety determined by number and severity of adverse events
|
From study start to completion; up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Indra Narang, MD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- 1000079288
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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