Trial Outcomes & Findings for Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment (NCT NCT01939938)

Results Overview

The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

through study completion, an average of 1 hour

Results posted on

2018-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects-Nasal and Oronasal PAP Mask Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects-Nasal and Oronasal PAP Mask n=10 Participants Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1 hour

The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.

Outcome measures

Outcome measures
Measure	Baseline AHI n=10 Participants AHI at baseline.	Residual AHI n=10 Participants AHI residual.
AHI	42.3 events per hour Standard Deviation 28.7	1.58 events per hour Standard Deviation 1.87

SECONDARY outcome

Timeframe: Approximately 1 hour

MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.

Outcome measures

Outcome measures
Measure	Baseline AHI n=10 Participants AHI at baseline.	Residual AHI AHI residual.
MRI of Upper Airway With Opposite PAP Mask	10 Participants	—

Adverse Events

All Subjects-Nasal and Oronasal PAP Mask

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

Dr. Matthew Ebben

Weill Cornell Medical College

Phone: 6469629318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place