Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02816255 |
| Other study ID # |
1602017026 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
March 9, 2018 |
Study information
| Verified date |
August 2022 |
| Source |
Weill Medical College of Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 two weeks.
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
1. 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)
2. 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.
1. 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).
2. The duration of the ≥30% drop in signal excursion is ≥10 seconds.
3. 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
