Sleep Apnea, ObstructiveNCT02515409
Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- HHHFNC and CPAP
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 0-16 years with obstractive sleep apnea, referred for treatment with non invasive ventilation.
Who may be able to join
- Age: 0-16 years old.
- Refered for treatment with non invasive ventilation.
- Diagnosed with OSAS and AHI>=5
- There are no exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- HHHFNC, CPAP
- Keywords
- Obstructive Sleep Apnea Syndrome (OSAS), Heated Humidified High Flow Nasal Cannula (HHHNC), Continues positive airway pressure (CPAP), Children, Non invasive ventilation, Treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHHFNCDevice
After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.
CPAPDevice
CPAP, as a first line treatment in OSAS.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | CPAP, as a first line treatment to OSAS. Receives: Device: CPAP | |
| HHHFNC | Treatment with HHHFNC after CPAP treatment fails. Receives: Device: HHHFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average hours per night and per week using HHHFNC .
Measured: One year
Average hours per night and per week using CPAP.
Measured: One year
Secondary outcomes (2)
Apnea hypopnea index (AHI)
Severity of sleep apnea using AHI.
Measured: One year
Pediatric sleep questionnaire (PSQ) score
Obstructive sleep-related breathing disorders using PSQ score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Keren Armoni-Domany, Dr., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515409
- Sponsor's protocol ID
- TASMC-15-KA-0263-15-TLV-CTIL
- Status last verified
- Jun 2015
- First submitted
- 28 Jun 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02515409
- Acronym / sponsor ID
- TASMC-15-KA-0263-15-TLV-CTIL
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea Syndrome (OSAS), Heated Humidified High Flow Nasal Cannula (HHHNC), Continues positive airway pressure (CPAP), Children, Non invasive ventilation, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- 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 purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | – | Device: CPAPCPAP, as a first line treatment to OSAS. |
| HHHFNC | – | Device: HHHFNCTreatment with HHHFNC after CPAP treatment fails. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 0-16 years with obstractive sleep apnea, referred for treatment with non invasive ventilation.
Key inclusion criteria (4 listed)
- Age: 0-16 years old.
- Refered for treatment with non invasive ventilation.
- Diagnosed with OSAS and AHI>=5
- There are no exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HHHFNCAfter the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS. | Device | HHHFNC |
| CPAPCPAP, as a first line treatment in OSAS. | Device | CPAP |
Primary outcome
Average hours per night and per week using HHHFNC .
Time frame: One year
Average hours per night and per week using CPAP.
Time frame: One year
2 secondary outcomes
Apnea hypopnea index (AHI)
Time frame: One year
Pediatric sleep questionnaire (PSQ) score
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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.
Keren Armoni-Domany, Dr. principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Tel-Aviv Sourasky Medical Center.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren Armoni-Domany, Dr. (+972-3-6974614, domany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average hours per night and per week using HHHFNC . (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2015.