High Flow Nasal Cannula Therapy for Childhood OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

High-flow Nasal Cannula as an Alternative Intervention for Children and Adolescents With Obstructive Sleep Apnoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933800
• Other study ID #: HFOSA1.0
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.

Children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy will be recruited.

In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.

Description:

Background: Obstructive sleep apnoea (OSA) is prevalent in school-aged children and is associated with significant morbidities. Poor compliance with positive airway pressure therapy remains an issue and leads to suboptimal treatment in children with OSA. Alternative therapeutic strategy is needed to manage this group of patients more effectively.

Objective: To evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.

Hypothesis: The investigators hypothesize that HFNC therapy is effective in reducing the severity of OSA in children.

Design: A 2-phase study - phase 1 is a single arm study to evaluate the efficacy of HFNC therapy in children with OSA, phase 2 is an intervention period to evaluate the compliance and quality of life with HFNC therapy.

Subjects: 46 children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy.

Methods: In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.

Primary outcome measure: Efficacy of the HFNC therapy, as defined by the change in OAHI from baseline to that with HFNC therapy.

Expected results: Efficacy data to determine whether HFNC therapy can be an alternative therapy for children with OSA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 31, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of moderate-to-severe OSA requiring CPAP therapy (Moderate-to-severe OSA is defined as an OAHI = 5 events per hour and reported history of habitual snoring of 3 nights or more per week)

Exclusion Criteria:

• Syndromal diseases;

• Cranio-facial anomalies;

• Pathological central apnoea, chronic respiratory failure or neuromuscular disease as they would require bilevel PAP;

• Secondary obesity e.g. Prader-Willi syndrome, Cushing's syndrome;

• History of pneumothorax or pneumomediastinum;

• Prior use of PAP or HFNC therapy;

• Refusal to use non-invasive ventilation.

Related Conditions & MeSH terms

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

Intervention

Device:
• High flow nasal cannula
High flow nasal cannula therapy
• Continuous positive airway pressure
Continuous positive airway pressure therapy

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the high flow nasal cannula (HFNC) therapy: the absolute change in obstructive apnea hypopnea index (OAHI) from baseline with the use of HFNC therapy	The change in obstructive apnea hypopnea index (OAHI) from baseline to that on HFNC therapy: obstructive apnoea hypopnoea index is the number of obstructive apnoea or hypopnoea events per hour of total sleep time (It is not a scale, minimum is 0 events/hour, there is no maximum score)	One night - titration study will be done overnight for one night to look at the improvement of OAHI from baseline to that with HFNC therapy
Secondary	Compliance to the therapy: percentage of subjects who are adherent to the therapy	Percentage of subjects who are adherent to the therapy, which is defined as >70% nightly use and average usage = 4 hours per night	3 months
Secondary	Quality of life measures - Modified Epworth Sleepiness Scale	Modified Epworth Sleepiness Scale (ESS) to assess the daytime sleepiness - ESS score is the sum of the eight item scores ranging from 0 to 24, where a higher score represents greater sleepiness.	3 months
Secondary	Quality of life measures - Pediatric Quality of Life Inventory	Pediatric Quality of Life Inventory (PedsQL) - 23-item PedsQL Generic Core Scales will measure the core dimensions of health as delineated by the World Health Organisation, as well as role functioning. Four dimensions, physical, emotional, social and school functioning, will be measured. For physical functioning, score ranges from 1 to 8. For emotional, social and school functioning, scores range from 1 to 5. Higher scores indicate better quality of life.	3 months
Secondary	Quality of life measures - OSAS-18	OSAS-18 is a questionnaire with composite of OSAS-related symptoms and disease-specific quality of life. Score ranges from 18 to 126; 18 - 60 indicates small impact on health-related quality of life; 60 to 80 indicates moderate impact; >80 indicates severe impact.	3 months
Secondary	Neurobehavioural surveys - Child Behaviour Checklist	Child Behaviour Checklist is a survey of behaviour competencies that yields standardised, age-adjusted scores on internalizing, externalizing and total behaviour difficulties	3 months