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

NCT05354401 | Completed

• 1 other identifier: 1000054076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparative COMFORT scales with HHF and CPAP.

  week 1-4

Study Arms (2)

Obese

ACTIVE COMPARATOR

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

CMC

ACTIVE COMPARATOR

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

Interventions

HHF 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; Obese

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• CMC recently diagnosed with moderate to severe OSA or CSA requiring CPAP therapy
• 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
• Current upper respiratory tract infection
• Subjects who are receiving oxygen therapy

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X9, Canada

Location

Related Publications (1)

• 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.

  PMID: 37148831 DERIVED

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Indra Narang, BMEDSci, MBBCH, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: March 1, 2019
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CA (1)