Trial Outcomes & Findings for Servo-Ventilation In-lab PSG Evaluation (NCT NCT02808338)

Last Updated: 2019-03-19

Results Overview

The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

4 nights

Results posted on

2019-03-19

Participant Flow

A multi-site study that accrued over 2016 and into the middle of 2017.

Participant milestones

Participant milestones
Measure	Screening All participants that consented to the study were considered for the participant flow. 15 participants were randomized to participate in the overnight in lab PSG's, these overnights were randomized to 1 of 4 interventions for each of the 4 overnights. This randomization scheme resulted in a large number of device sequences.
Screening STARTED	25
Screening COMPLETED	15
Screening NOT COMPLETED	10
Overnight In-lab Polysomonography STARTED	15
Overnight In-lab Polysomonography Modified Philips BiPAP ASV	13
Overnight In-lab Polysomonography ResMed S7 VPAP Adapt	13
Overnight In-lab Polysomonography Philips BiPAP AutoSV Advanced System One	12
Overnight In-lab Polysomonography ResMed S9 VPAP Adapt	12
Overnight In-lab Polysomonography COMPLETED	13
Overnight In-lab Polysomonography NOT COMPLETED	2
Take Home Period STARTED	13
Take Home Period COMPLETED	13
Take Home Period NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Screening All participants that consented to the study were considered for the participant flow. 15 participants were randomized to participate in the overnight in lab PSG's, these overnights were randomized to 1 of 4 interventions for each of the 4 overnights. This randomization scheme resulted in a large number of device sequences.
Screening Screen Failure	10
Overnight In-lab Polysomonography Withdrawal by Subject	1
Overnight In-lab Polysomonography Reason not given	1

Baseline Characteristics

Servo-Ventilation In-lab PSG Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening n=20 Participants All participants that consented to the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 nights

Population: 1 participant was excluded because he did not meet the criteria to receive ASV.

The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.