Dexamethasone Treatment for OSA in Children

Obstructive Sleep Apnea Clinical Trial

Official title:

Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638087
• Other study ID #: 1000079288
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Mystica Terrance, BSc
• Phone: 6479261307
• Email: mystica.terrance[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Dexamethasone
Dexamethasone Oral Suspension
• Placebo Control
Placebo Oral Mix

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive apnea-hypopnea index	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	Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score	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
Secondary	Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)	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
Secondary	Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.	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
Secondary	Soft tissue size (Adenoids, Tonsils & Turbinates)	Change in soft tissue size (adenoids, tonsils and turbinates) from baseline	Baseline and 2-4 weeks
Secondary	Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline	Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA	At baseline
Secondary	Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)	Cells from nasal brushing will be cultured and harvested for RNA to study gene expression.	At baseline
Secondary	Participant recruitment rate	Feasibility determined by participant recruitment rate	From study start to completion; up to 6 months
Secondary	Participant retention rate	Feasibility determined by participant retention rate	From study start to completion; up to 6 months
Secondary	Participant adherence rate	Feasibility determined by participant adherence rate	From study start to completion; up to 6 months
Secondary	Adverse events	Safety determined by number and severity of adverse events	From study start to completion; up to 6 months