Trial Outcomes & Findings for Comparison of Auto-Adjusting Positive Airway Pressure Devices (NCT NCT02357706)

Results Overview

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)

Results posted on

2020-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	APAP A, Then APAP B Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events	APAP B, Then APAP A Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Auto-Adjusting Positive Airway Pressure Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=20 Participants Patients will be randomised to either "APAP A, then APAP B" or "APAP B, then APAP A". Patients in "APAP A, then APAP B" will use APAP A on the first night of the evaluation, and APAP B on the second night. Patients in "APAP B, then APAP A" will use APAP B on the first night of the evaluation and APAP A on the second night. APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Age, Continuous	57.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 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
Body Mass Index (BMI)	31.1 kg/m2 STANDARD_DEVIATION 5.3 • n=5 Participants
Neck Size	41.1 cm STANDARD_DEVIATION 3.6 • n=5 Participants
waist-to-hip ratio	1.01 ratio STANDARD_DEVIATION 0.06 • n=5 Participants

PRIMARY outcome

Timeframe: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)

Population: 20 patients have used APAP A, for which the primary outcome was calculated. The same 20 patients have used APAP B for which the Primary outcome was calculated.

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Outcome measures

Outcome measures
Measure	APAP A (AirSense Auto Set) n=20 Participants Patients in the "APAP A, then APAP B" group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A. APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events	APAP B (Apex iCH Auto) n=20 Participants Patients in the "APAP B, then APAP A" group will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A. APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Mean Apnoea-Hypopnoea-Index (AHI)	6.21 events/hour Standard Deviation 6.73	7.45 events/hour Standard Deviation 7.57

PRIMARY outcome

Timeframe: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.

Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour