High Flow Nasal Cannula Therapy for Childhood OSA

NCT03933800 | Completed

• 1 other identifier: HFOSA1.0
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Therapy; High flow nasal cannula; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compliance to the therapy: percentage of subjects who are adherent to the therapy

  3 months

• Quality of life measures - Modified Epworth Sleepiness Scale

  3 months

• Quality of life measures - Pediatric Quality of Life Inventory

  3 months

• Quality of life measures - OSAS-18

  3 months

• Neurobehavioural surveys - Child Behaviour Checklist

  3 months

Study Arms (2)

High flow nasal cannula (HFNC)

EXPERIMENTAL

High flow nasal cannula therapy

Device: High flow nasal cannula

Continuous positive airway pressure (CPAP)

ACTIVE COMPARATOR

Continuous positive airway pressure therapy

Device: Continuous positive airway pressure

Interventions

High flow nasal cannula DEVICE

High flow nasal cannula therapy

High flow nasal cannula (HFNC)

Continuous positive airway pressure DEVICE

Continuous positive airway pressure therapy

Continuous positive airway pressure (CPAP)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Kate C Chan, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: July 1, 2019
• Primary Completion: March 15, 2024
• Study Completion: May 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)