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

NCT ID: NCT05354401

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-03-02

Brief Summary

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

Conditions

Obesity; Obstructive Sleep Apnea (Moderate to Severe); Central Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

HHF

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

HHF

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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:

• Current upper respiratory tract infection
• Subjects who are receiving oxygen therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Indra Narang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indra Narang, BMEDSci, MBBCH, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37148831 (View on PubMed)

Other Identifiers

1000054076

Identifier Type: -

Identifier Source: org_study_id