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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Central Sleep Apnea; Obstructive Sleep Apnea (Moderate to Severe)
• Intervention / Treatment: Other: HHF

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Deonarain; Phone Number: 416-813-6809; Email: christina.deonarain@sickkids.ca
• Study Contact Backup: Name: Indra Narang; Phone Number: 416-813-6346; Email: indra.narang@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X9
      • Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Obese; 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; 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.
Active Comparator: CMC; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Indra Narang, BMEDSci, MBBCH, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: 1000054076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No