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

Not Applicable

Completed

• Conditions: Central Sleep Apnea; Obesity; Obstructive Sleep Apnea (Moderate to Severe)
• Interventions: Other: HHF

• Registration Number: NCT05354401
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Obese	HHF	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.
CMC	HHF	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparative COMFORT scales with HHF and CPAP.	week 1-4	Determine whether COMFORT scale scores differ between HHF and CPAP

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada