Trial Outcomes & Findings for The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface. (NCT NCT02816255)

Last Updated: 2022-09-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

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).

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Full Face Mask With Same CPAP Pressure After the two week period all will switch to a full face mask with half using the same CPAP pressure. Full Face Mask with same CPAP Pressure: Full Face Mask with same CPAP Pressure	Full Face Mask With New 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. Full Face Mask with new Pressure: New cpap pressure derived from our formula for the final two weeks.
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Face Mask With Same CPAP Pressure n=6 Participants After the two week period all will switch to a full face mask with half using the same CPAP pressure. Full Face Mask with same CPAP Pressure: Full Face Mask with same CPAP Pressure	Full Face Mask With New Pressure n=5 Participants 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. Full Face Mask with new Pressure: New cpap pressure derived from our formula for the final two weeks.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Full Face Mask With Same CPAP Pressure n=6 Participants After the two week period all will switch to a full face mask with half using the same CPAP pressure. Full Face Mask with same CPAP Pressure: Full Face Mask with same CPAP Pressure	Full Face Mask With New Pressure n=5 Participants 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. Full Face Mask with new Pressure: New cpap pressure derived from our formula for the final two weeks.
Change in Severity of Sleep Apnea as Measured by the AHI	2.81 AHI Standard Deviation 1.59	1.59 AHI Standard Deviation 1.47

SECONDARY outcome

Timeframe: One month

Population: We were unable to collect oximetry data in either the treatment or control groups.

The investigators will compare the lowest oxyhemoglobin saturation of subjects with the new formula in place vs. those that don't have the formula.

Outcome measures

Outcome data not reported

Adverse Events

Full Face Mask With New Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Full Face Mask With Same CPAP Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew R. Ebben, Ph.D.

Weill Cornell Medicine

Phone: 646-962-9313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place