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The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese | Active Comparator | 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. |
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| CMC | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HHF | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in apnea-hypopnea index (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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative COMFORT scales with HHF and CPAP. | Determine whether COMFORT scale scores differ between HHF and CPAP | week 1-4 |
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OBESE SUBJECTS:
Inclusion Criteria:
Exclusion Criteria:
CHILDREN WITH MEDICAL COMPLEXITY SUBJECTS:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indra Narang, BMEDSci, MBBCH, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Sick Children | Toronto | Ontario | M5G 1X9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37148831 | Derived | Fishman H, Al-Shamli N, Sunkonkit K, Maguire B, Selvadurai S, Baker A, Amin R, Propst EJ, Wolter NE, Eckert DJ, Cohen E, Narang I. Heated humidified high flow nasal cannula therapy in children with obstructive sleep apnea: A randomized cross-over trial. Sleep Med. 2023 Jul;107:81-88. doi: 10.1016/j.sleep.2023.04.017. Epub 2023 Apr 21. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |