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Completed

NCT Number: NCT05354401

Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents

The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.

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Key information

Conditions

Obesity Apnea Body Weight Central Sleep Apnea Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obstructive Sleep Apnea (Moderate to Severe) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

OBESE SUBJECTS:

Inclusion criteria

  • Obesity, defined as a BMI > 95th percentile for age and gender
  • Age 10 through 18 years
  • Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study
  • Moderate-severe OSA or Central Sleep Apnea (CSA) as defined by OAHI or CAHI

Exclusion criteria

  • Patients with other neurological problems, including but not limited to neurocutaneous disorders such as neurofibromatosis or tuberous sclerosis
  • Obesity due to other diseases and syndromes (e.g. Prader-Willi syndrome)
  • Pregnancy
  • Currently unwell, hospitalized or recent viral/bacterial infection in the previous 4 weeks
  • Adenoidal and/or tonsillar hypertrophy which may be amenable to surgical intervention to help alleviate OSA
  • Patients with severe respiratory distress
  • Patients with increased risk of pneumothorax including but not limited to previous pneumothorax, bronchiectasis or severe untreated asthma.

CHILDREN WITH MEDICAL COMPLEXITY SUBJECTS:

Inclusion criteria

  • CMC recently diagnosed with moderate to severe OSA or CSA requiring CPAP therapy
  • 0-18 years of age
  • Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study

Exclusion criteria

  • Current upper respiratory tract infection
  • Subjects who are receiving oxygen therapy

Treatment and study plan

HHF

Other

HHF is an integrated flow generator that delivers heated and humidified air or oxygen at high flow rates via a soft nasal cannula using an open circuit. HHF via the Fisher and Paykel myAIRVO 2 device will be initiated as per The Hospital for Sick Children's sleep laboratory standard protocol by a sleep technician or respiratory therapist (RT) during an overnight polysomnography. Nasal prongs will be selected that are less than fifty percent of the subject's nares. The lowest flow rate of HHF will be selected and titrated upwards until clinical effect is achieved, to a maximum flow of 60L/minute, as per standard clinical care.

Primary outcomes

  1. Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP

    Time frame: week 1-4

    Determine whether a participant's AHI changes with HHF vs CPAP

Secondary outcomes

  1. Comparative COMFORT scales with HHF and CPAP.

    Time frame: week 1-4

    Determine whether COMFORT scale scores differ between HHF and CPAP

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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