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The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full Face Mask with same CPAP Pressure
Full Face Mask with new Pressure
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Weill Cornell Medicine Center for Sleep Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Full Face Mask with same CPAP Pressure

Full Face Mask with new Pressure

Arm Description

After the two week period all will switch to a full face mask with half using the same CPAP pressure.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2016
Last Updated
August 30, 2022
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT02816255
Brief Title
The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
Official Title
The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to budget and staff changes due to covid-19.
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full Face Mask with same CPAP Pressure
Arm Type
Placebo Comparator
Arm Description
After the two week period all will switch to a full face mask with half using the same CPAP pressure.
Arm Title
Full Face Mask with new Pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Full Face Mask with same CPAP Pressure
Intervention Description
Full Face Mask with same CPAP Pressure
Intervention Type
Device
Intervention Name(s)
Full Face Mask with new Pressure
Intervention Description
New cpap pressure derived from our formula for the final two weeks.
Primary Outcome Measure Information:
Title
Change in Severity of Sleep Apnea as Measured by the AHI
Description
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.
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).
Secondary Outcome Measure Information:
Title
Lowest Oxyhemoglobin Saturation
Description
The investigators will compare the lowest oxyhemoglobin saturation of subjects with the new formula in place vs. those that don't have the formula.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Ebben, Ph. D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine Center for Sleep Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.

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