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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05354401
• Other study ID #: 1000054076
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 2, 2023

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparative COMFORT scales with HHF and CPAP.	Determine whether COMFORT scale scores differ between HHF and CPAP	week 1-4