Obstructive Sleep Apnea (OSA)NCT02816255
The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
A study testing Full Face Mask with same CPAP Pressure and Full Face Mask with new Pressure in people with Obstructive Sleep Apnea (OSA), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Full Face Mask with same CPAP Pressure and Full Face Mask with new Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI above 15.
- Willing to switch to full face mask post titration.
- Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study
Who cannot join
- AHI below 15.
- Not willing to switch to full face mask post titration.
- Currently on a weight loss plan and / or intention of beginning a weight loss regimen during the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine Center for Sleep Medicine
New York, New York, 10065
About this study
Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final two weeks.
Read the detailed description
The goal of this study is to test the efficacy of an algorithm the investigators previously created to adjust Continuous positive airway pressure (CPAP) when a mask interface is switched from a nasal to a full face.
Subjects will currently have a moderate to severe Apnea-hypopnea index (AHI - The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep). (above 15)
- Scoring of apneas Score a respiratory event as an apnea when BOTH of the following criteria are met: N1, N2, N3, N4
- There is a drop in the peak signal excursion by ≥90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study)
- The duration of the ≥90% drop in sensor signal is ≥ 10 seconds. Score an apnea as obstructive if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow. Score an apnea as central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow. Score an apnea as mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event, followed by resumption of inspiratory effort in the second portion of the event. N4 Note 1 - Identification of an apnea does not require a minimum desaturation criterion. Note 2 - If a portion of a respiratory event that would otherwise meet criteria for a hypopnea meets criteria for apnea, the entire event should be scored an apnea. Note 3 - If the apnea or hypopnea event begins or ends during an epoch that is scored as sleep, then the corresponding respiratory event can be scored and included in the computation of the apnea hypopnea index (AHI). This situation usually occurs when an individual; has a high AHI with events occurring so frequently that sleep is severely disrupted and epochs may end up being scored as wake even though <15 seconds of sleep is present during the epoch containing that portion of the respiratory event. However if the apnea or hypopnea occurs entirely during an epoch scored as wake, it should not be scored or counted towards the apnea hypopnea index because of the difficultly of defining a denominator in this situation. If these occurrences are a prominent feature of the polysomnogram and/or interfere with sleep onset, their presence should be mentioned in the narrative summary if the study. Note 4 - For alternative apnea sensors see tech specifications for Adults. There is not sufficient evidence to support a specific durations of the central and obstructive components of a mixed apnea thus specific durations of these components are not recommended.
- AASM 2015 PROTOCOL Scoring of Hypopneas Score a respiratory event as a hypopnea if all of the following criteria are met. N1, N2, N3.
- The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure (diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor (diagnostic study).
- The duration of the ≥30% drop in signal excursion is ≥10 seconds.
- There is a ≥3% oxygen desaturation from pre-event baseline or the event is associated with an arousal.
Subjects once consented and entered into the study, will all have a two week baseline period in which they will use a nasal mask using an airview cpap machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new cpap pressure derived from our formula for the final two weeks.
Those placed in the randomized into a new pressure will have an experimental procedure of getting a new pressure.
The investigators expect the AHI of the controls to increase. Our two new formulas are referred to as Opred (oronasal) (full face mask) and Npred (nasal) (non-full face mask).
Npred=(0.017 AHI)-(0.092 LSaO2)+(0.225 NC)+5.534 Opred=(0.03 AHI)-(0.130 LSaO2)+19.732 NC=Neck circumference, AHI= baseline AHI, LSaO2= Lowest blood oxygen saturation from the baseline polysomnogram.
These models were developed using multiple linear regressing modeling. The study is self-funded because it has no funding. Subjects will not be compensated
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Full Face Mask with same CPAP Pressure, Full Face Mask with new Pressure
- 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.
Full Face Mask with same CPAP PressureDevice
Full Face Mask with same CPAP Pressure
Full Face Mask with new PressureDevice
New cpap pressure derived from our formula for the final two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Full Face Mask with same CPAP Pressure | Placebo comparator | After the two week period all will switch to a full face mask with half using the same CPAP pressure. Receives: Device: Full Face Mask with same CPAP Pressure |
| Full Face Mask with new Pressure | Active comparator | After the two week period all will switch to a full face mask with half using with a new cpap pressure derived from our formula. Receives: Device: Full Face Mask with new Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Sleep Apnea as Measured by the AHI
The investigators will compare the Apnoea-Hypopnoea Index (AHI) of subjects with the new formula in place vs. those that don't have the formula. The Apnea-Hypopnea Index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. A respiratory event is scored as an apnea when both of the following criteria are met: N1, N2, N3, N4. a) There is a drop in the peak signal excursion by greater than or equal to 90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study) b) The duration of the greater than or equal to 90% drop in sensor signal is greater than or equal to 10 seconds.
Measured: After a 2-week baseline period (for weeks 3 & 4), subjects will be switched from a nasal to full-face CPAP mask interface for two-weeks with either the same CPAP setting (control) or a new formula determined pressure (treatment).
Secondary outcomes (1)
Lowest Oxyhemoglobin Saturation
The investigators will compare the lowest oxyhemoglobin saturation of subjects with the new formula in place vs. those that don't have the formula.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2017
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Why it stopped: Due to budget and staff changes due to covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will complete two week baseline with nasal mask then will complete two week treatment with full face either with new algorithm or old algorithm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Ebben, Ph. D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816255
- Sponsor's protocol ID
- 1602017026
- Status last verified
- Aug 2022
- First submitted
- 23 Jun 2016
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
- ClinicalTrials.gov ID
- NCT02816255
- Acronym / sponsor ID
- 1602017026
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to budget and staff changes due to covid-19.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final two weeks.
Detailed description
The goal of this study is to test the efficacy of an algorithm the investigators previously created to adjust Continuous positive airway pressure (CPAP) when a mask interface is switched from a nasal to a full face.
Subjects will currently have a moderate to severe Apnea-hypopnea index (AHI - The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep). (above 15)
- Scoring of apneas Score a respiratory event as an apnea when BOTH of the following criteria are met: N1, N2, N3, N4
- There is a drop in the peak signal excursion by ≥90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study)
- The duration of the ≥90% drop in sensor signal is ≥ 10 seconds. Score an apnea as obstructive if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow. Score an apnea as central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow. Score an apnea as mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event, followed by resumption of inspiratory effort in the second portion of the event. N4 Note 1 - Identification of an apnea does not require a minimum desaturation criterion. Note 2 - If a portion of a respiratory event that would otherwise meet criteria for a hypopnea meets criteria for apnea, the entire event should be scored an apnea. Note 3 - If the apnea or hypopnea event begins or ends during an epoch that is scored as sleep, then the corresponding respiratory event can be scored and included in the computation of the apnea hypopnea index (AHI). This situation usually occurs when an individual; has a high AHI with events occurring so frequently that sleep is severely disrupted and epochs may end up being scored as wake even though <15 seconds of sleep is present during the epoch containing that portion of the respiratory event. However if the apnea or hypopnea occurs entirely during an epoch scored as wake, it should not be scored or counted towards the apnea hypopnea index because of the difficultly of defining a denominator in this situation. If these occurrences are a prominent feature of the polysomnogram and/or interfere with sleep onset, their presence should be mentioned in the narrative summary if the study. Note 4 - For alternative apnea sensors see tech specifications for Adults. There is not sufficient evidence to support a specific durations of the central and obstructive components of a mixed apnea thus specific durations of these components are not recommended.
- AASM 2015 PROTOCOL Scoring of Hypopneas Score a respiratory event as a hypopnea if all of the following criteria are met. N1, N2, N3.
- The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure (diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor (diagnostic study).
- The duration of the ≥30% drop in signal excursion is ≥10 seconds.
- There is a ≥3% oxygen desaturation from pre-event baseline or the event is associated with an arousal.
Subjects once consented and entered into the study, will all have a two week baseline period in which they will use a nasal mask using an airview cpap machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new cpap pressure derived from our formula for the final two weeks.
Those placed in the randomized into a new pressure will have an experimental procedure of getting a new pressure.
The investigators expect the AHI of the controls to increase. Our two new formulas are referred to as Opred (oronasal) (full face mask) and Npred (nasal) (non-full face mask).
Npred=(0.017 AHI)-(0.092 LSaO2)+(0.225 NC)+5.534 Opred=(0.03 AHI)-(0.130 LSaO2)+19.732 NC=Neck circumference, AHI= baseline AHI, LSaO2= Lowest blood oxygen saturation from the baseline polysomnogram.
These models were developed using multiple linear regressing modeling. The study is self-funded because it has no funding. Subjects will not be compensated
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will complete two week baseline with nasal mask then will complete two week treatment with full face either with new algorithm or old algorithm.
| Arm | Type | Receives |
|---|---|---|
| Full Face Mask with same CPAP Pressure | Placebo comparator | Device: Full Face Mask with same CPAP PressureAfter the two week period all will switch to a full face mask with half using the same CPAP pressure. |
| Full Face Mask with new Pressure | Active comparator | Device: Full Face Mask with new PressureAfter the two week period all will switch to a full face mask with half using with a new cpap pressure derived from our formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI above 15.
- Willing to switch to full face mask post titration.
- Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study
Key exclusion criteria (3 listed)
- AHI below 15.
- Not willing to switch to full face mask post titration.
- Currently on a weight loss plan and / or intention of beginning a weight loss regimen during the duration of the study.
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 |
|---|---|---|
| Full Face Mask with same CPAP PressureFull Face Mask with same CPAP Pressure | Device | Full Face Mask with same CPAP Pressure |
| Full Face Mask with new PressureNew cpap pressure derived from our formula for the final two weeks. | Device | Full Face Mask with new Pressure |
Primary outcome
Change in Severity of Sleep Apnea as Measured by the AHI
Time frame: After a 2-week baseline period (for weeks 3 & 4), subjects will be switched from a nasal to full-face CPAP mask interface for two-weeks with either the same CPAP setting (control) or a new formula determined pressure (treatment).
The investigators will compare the Apnoea-Hypopnoea Index (AHI) of subjects with the new formula in place vs. those that don't have the formula. The Apnea-Hypopnea Index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. A respiratory event is scored as an apnea when both of the following criteria are met: N1, N2, N3, N4. a) There is a drop in the peak signal excursion by greater than or equal to 90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study) b) The duration of the greater than or equal to 90% drop in sensor signal is greater than or equal to 10 seconds.
1 secondary outcome
Lowest Oxyhemoglobin Saturation
Time frame: One month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Matthew Ebben, Ph. D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Face Mask with same CPAP Pressure and Full Face Mask with new Pressure in people with Obstructive Sleep Apnea (OSA), run by Weill Medical College of Cornell University at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Sep 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Severity of Sleep Apnea as Measured by the AHI (time frame: After a 2-week baseline period (for weeks 3 & 4), subjects will be switched from a nasal to full-face CPAP mask interface for two-weeks with either the same CPAP setting (control) or a new formula determined pressure (treatment).). 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 28 Sep 2022.