Trial Outcomes & Findings for Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP (NCT NCT01909674)

NCT ID: NCT01909674

Last Updated: 2017-05-17

Results Overview

Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 weeks for each mask condition
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Oronasal Mask Initial administration of oronasal CPAP mask Switch CPAP mask type	Nasal Mask Initial administration of nasal CPAP mask Switch CPAP mask type
Overall Study STARTED	12	9
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Oronasal Mask Initial administration of oronasal CPAP mask Switch CPAP mask type	Nasal Mask Initial administration of nasal CPAP mask Switch CPAP mask type
Overall Study Withdrawal by Subject	5	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Oronasal Mask n=12 Participants Initial administration of oronasal CPAP mask Switch CPAP mask type	Nasal Mask n=9 Participants Initial administration of nasal CPAP mask Switch CPAP mask type	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=9 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=12 Participants	9 Participants n=9 Participants	20 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=12 Participants	0 Participants n=9 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=12 Participants	1 Participants n=9 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=12 Participants	8 Participants n=9 Participants	19 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 Participants n=12 Participants	9 Participants n=9 Participants	21 Participants n=21 Participants

PRIMARY outcome

Timeframe: 3 weeks for each mask condition

Population: higher values represent a better outcome

Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

Outcome measures

Measure	Total Sleep Time - Nasal Mask n=7 Participants Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.	Total Sleep Time (TST) Oronasal Mask n=7 Participants Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks	332.64 minutes Standard Deviation 92.09	346.79 minutes Standard Deviation 86.74

Adverse Events

Oronasal Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nasal 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: mae2001@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place