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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HHF
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Obese

CMC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in AHI with HHF compared to the change in AHI with CPAP
Determine whether a participant's AHI changes with HHF vs CPAP

Secondary Outcome Measures

Comparative COMFORT scales with HHF and CPAP.
Determine whether COMFORT scale scores differ between HHF and CPAP

Full Information

First Posted
April 25, 2022
Last Updated
April 25, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT05354401
Brief Title
Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
Official Title
Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obstructive Sleep Apnea (Moderate to Severe), Central Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obese
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CMC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HHF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in AHI with HHF compared to the change in AHI with CPAP
Description
Determine whether a participant's AHI changes with HHF vs CPAP
Time Frame
week 1-4
Secondary Outcome Measure Information:
Title
Comparative COMFORT scales with HHF and CPAP.
Description
Determine whether COMFORT scale scores differ between HHF and CPAP
Time Frame
week 1-4

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Deonarain
Phone
416-813-6809
Email
christina.deonarain@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Indra Narang
Phone
416-813-6346
Email
indra.narang@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indra Narang, BMEDSci, MBBCH, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Deonarain
Phone
416-813-6809
Email
christina.deonarain@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Indra Narang, BMedSci, MBBCH, MD
Phone
416-813-6346
Email
indra.narang@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Indra Narang, BMedSci, MBBCH, MD

12. IPD Sharing Statement

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

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