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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT05354401

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Obstructive Sleep Apnea (Moderate to Severe) Central Sleep Apnea	Other: HHF	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Mar 2, 2023

Anticipated Study Completion Date :

Mar 2, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change in 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

Comparative COMFORT scales with HHF and CPAP. [week 1-4]
Determine whether COMFORT scale scores differ between HHF and CPAP

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X9

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Indra Narang, Principal Investigator, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT05354401

Other Study ID Numbers:

1000054076

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Sleep Apnea, Central

Obesity

Study Results

No Results Posted as of Apr 29, 2022