High Flow Nasal Cannula Therapy for Childhood OSA

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT03933800

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: High flow nasal cannula Device: Continuous positive airway pressure	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High flow nasal cannula (HFNC) High flow nasal cannula therapy	Device: High flow nasal cannula High flow nasal cannula therapy
Active Comparator: Continuous positive airway pressure (CPAP) Continuous positive airway pressure therapy	Device: Continuous positive airway pressure Continuous positive airway pressure therapy

Arm

Intervention/Treatment

Experimental: High flow nasal cannula (HFNC)

High flow nasal cannula therapy

Device: High flow nasal cannula

High flow nasal cannula therapy

Active Comparator: Continuous positive airway pressure (CPAP)

Continuous positive airway pressure therapy

Device: Continuous positive airway pressure

Continuous positive airway pressure therapy

Outcome Measures

Primary Outcome Measures

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 [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]
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)

Secondary Outcome Measures

Compliance to the therapy: percentage of subjects who are adherent to the therapy [3 months]
Percentage of subjects who are adherent to the therapy, which is defined as >70% nightly use and average usage ≥ 4 hours per night
Quality of life measures - Modified Epworth Sleepiness Scale [3 months]
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.
Quality of life measures - Pediatric Quality of Life Inventory [3 months]
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.
Quality of life measures - OSAS-18 [3 months]
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.
Neurobehavioural surveys - Child Behaviour Checklist [3 months]
Child Behaviour Checklist is a survey of behaviour competencies that yields standardised, age-adjusted scores on internalizing, externalizing and total behaviour difficulties

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.