ObesityNCT05354401
Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
A study testing HHF in people with Obesity and Obstructive Sleep Apnea (Moderate to Severe), run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea (Moderate to Severe), Central Sleep Apnea
- What is being tested?
- HHF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
- Being tested
- HHF
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: HHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 1-4
Secondary outcomes (1)
Comparative COMFORT scales with HHF and CPAP.
Determine whether COMFORT scale scores differ between HHF and CPAP
Measured: week 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Mar 2019
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, BMEDSci, MBBCH, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354401
- Sponsor's protocol ID
- 1000054076
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37148831
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
- ClinicalTrials.gov ID
- NCT05354401
- Acronym / sponsor ID
- 1000054076
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Active comparator | Other: HHFObese 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. |
| CMC | Active comparator | Other: HHFAs 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HHFHHF 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. | Other | CMC, Obese |
Primary outcome
Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP
Time frame: week 1-4
Determine whether a participant's AHI changes with HHF vs CPAP
1 secondary outcome
Comparative COMFORT scales with HHF and CPAP.
Time frame: week 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 37148831Fishman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indra Narang, BMEDSci, MBBCH, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHF in people with Obesity and Obstructive Sleep Apnea (Moderate to Severe), run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP (time frame: week 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.