Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
Sponsored by The Hospital for Sick Children
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the Participation Requirements?
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