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

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

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

Conditions
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Obesity, Obstructive Sleep Apnea (Moderate to Severe), Central Sleep Apnea

Intervention / Treatment
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* Other: HHF


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Obese<br>Obese subjects ages 10-18 years with OSA will be recruited from sleep clinic. As per standard clinic care, once a subject is diagnosed with OSA on a PSG they are reviewed in sleep clinic to discuss CPAP therapy. Families will be approached to participate in this study during the subject's regularly scheduled clinical visit. Obese subjects meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in the study. | Other: HHF<br>* 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.<br>|
| Active Comparator: CMC<br>As per current standard clinical care, CMC diagnosed with moderate to severe OSA following a clinically indicated baseline PSG who have had a previous adenotonsillectomy or who are not considered candidates for surgery are reviewed in sleep clinic to discuss the prescription of CPAP for OSA. CMC subjects' meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in this study. | Other: HHF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI with HHF compared to the change in AHI with CPAP | Determine whether a participant's AHI changes with HHF vs CPAP | week 1-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative COMFORT scales with HHF and CPAP. | Determine whether COMFORT scale scores differ between HHF and CPAP | week 1-4 |