Central Sleep Apnea, Obesity, Obstructive Sleep Apnea (Moderate to Severe)
Conditions
Brief summary
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
Interventions
OTHERHHF
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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP | week 1-4 | Determine whether a participant's AHI changes with HHF vs CPAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative COMFORT scales with HHF and CPAP. | week 1-4 | Determine whether COMFORT scale scores differ between HHF and CPAP |
Countries
Canada
Outcome results
None listed