Status:
COMPLETED
Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Obesity
Obstructive Sleep Apnea (Moderate to Severe)
Eligibility:
All Genders
Phase:
NA
Brief Summary
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
Eligibility Criteria
Inclusion
- OBESE SUBJECTS:
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05354401
Start Date
March 1 2019
End Date
March 2 2023
Last Update
January 18 2024
Active Locations (1)
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1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X9