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High Flow Nasal Cannula Therapy for Childhood OSA

  • Clinicaltrials.gov identifier

    NCT03933800

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    May 1, 2019

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:Obstructive Sleep Apnea
  • Intervention/Treatment: Device: High flow nasal cannula
    Device: Continuous positive airway pressure
  • Phase: 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
  • Estimated 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
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021

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

Outcome Measures

  • Primary Outcome Measures: 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 [ Time Frame: 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: 1. Compliance to the therapy: percentage of subjects who are adherent to the therapy [ Time Frame: 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
  • 2. Quality of life measures - Modified Epworth Sleepiness Scale [ Time Frame: 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.
  • 3. Quality of life measures - Pediatric Quality of Life Inventory [ Time Frame: 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.
  • 4. Quality of life measures - OSAS-18 [ Time Frame: 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.
  • 5. Neurobehavioural surveys - Child Behaviour Checklist [ Time Frame: 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

  • Ages Eligible for Study: 6 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Kate C Chan, MBChB 35052849 katechan@cuhk.edu.hk

Locations

Hong Kong
Prince of Wales Hospital
Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Kate C Chan, MBChB Chinese University of Hong Kong

More Information

  • Responsible Party: Chinese University of Hong Kong
  • ClinicalTrials.gov Identifier: NCT03933800 History of Changes
  • Other Study ID Numbers: HFOSA1.0
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Chinese University of Hong Kong: Therapy
    High flow nasal cannula
    Children
    Adolescents
  • Additional relevant MeSH terms: Sleep Apnea Syndromes Sleep Apnea, Obstructive