Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents (NCT05354401) | Clinical Trial Compass
CompletedNot Applicable
Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
Canada20 participantsStarted 2019-03-01
Plain-language summary
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP