Sleep Apnea, ObstructiveNCT03017859
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
A study testing High flow nasal cannula in people with Sleep Apnea, Obstructive, run by Rabin Medical Center.
Trial summary
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
- Apnea Hypopnea Index (AHI)≥15
- Patient has difficulties to adjust or comply with CPAP treatment
- Signed Informed Consent Form
Who cannot join
- Patients who need bilevel positive airway pressure (BIPAP)
- Known carbon dioxide (CO2) retainers
- Weight change>10% compared to time of OSA diagnosis
- Clinically unstable patients
- Pregnant women or special populations (e.g. children or patients unable to give informed consent)
Trial locations and contacts
No sites are listed yet.
About this study
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.
Read the detailed description
A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- High flow nasal cannula
- 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.
High flow nasal cannulaDevice
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula treatment | Experimental | Airvo 2 device will be used to administer high flow air during the night Receives: Device: High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
Measured: During at least 2 hours of sleep time
Secondary outcomes (5)
Percent of hypoxemia time
O2 saturation (SO2)<90% as measured by pulse oximeter
Measured: During at least 2 hours of sleep time
Minimal SO2%
Measured: During at least 2 hours of sleep time
Adverse events reported while using HFNC
Measured: During at least 2 hours of sleep time
Sleep efficiency
Measured: During at least 2 hours of sleep time
Total sleep time
Measured: During at least 2 hours of sleep time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
- Investigators
- Mordechai R Kramer, MD, Principal investigator, Pulmonary Institute, Rabin Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017859
- Sponsor's protocol ID
- RMC-16-0152
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03017859
- Acronym / sponsor ID
- RMC-16-0152
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Jan 2017 (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.
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.
Detailed description
A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula treatment | Experimental | Device: High flow nasal cannulaAirvo 2 device will be used to administer high flow air during the night |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years
- Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
- Apnea Hypopnea Index (AHI)≥15
- Patient has difficulties to adjust or comply with CPAP treatment
- Signed Informed Consent Form
Key exclusion criteria (5 listed)
- Patients who need bilevel positive airway pressure (BIPAP)
- Known carbon dioxide (CO2) retainers
- Weight change>10% compared to time of OSA diagnosis
- Clinically unstable patients
- Pregnant women or special populations (e.g. children or patients unable to give informed consent)
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 |
|---|---|---|
| High flow nasal cannulaWe shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep. | Device | High flow nasal cannula treatment |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: During at least 2 hours of sleep time
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
5 secondary outcomes
Percent of hypoxemia time
Time frame: During at least 2 hours of sleep time
Minimal SO2%
Time frame: During at least 2 hours of sleep time
Adverse events reported while using HFNC
Time frame: During at least 2 hours of sleep time
Sleep efficiency
Time frame: During at least 2 hours of sleep time
Total sleep time
Time frame: During at least 2 hours of sleep time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Mordechai R Kramer, MD principal investigator
Pulmonary Institute, Rabin Medical Center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula in people with Sleep Apnea, Obstructive, run by Rabin 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 5 inclusion and 5 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 11 Jan 2017. 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 Avraham Unterman, MD (972-39377221, ramiun@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) (time frame: During at least 2 hours of sleep time). 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 11 Jan 2017.