Trial Outcomes & Findings for ApneaLink Air Home Sleep Testing (HST) Device Validation Study (NCT NCT03470493)

NCT ID: NCT03470493

Last Updated: 2021-05-20

Results Overview

The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines. The REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2021-05-20

Participant Flow

Participant milestones

Measure	Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Overall Study STARTED	130
Overall Study Met Primary Endpoint	80
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Baseline characteristics by cohort

Measure	Participants n=80 Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Age, Continuous	53.2 years STANDARD_DEVIATION 13.0 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	57 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	74 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	80 participants n=93 Participants
Body Mass Index	35.1 kg/m^2 STANDARD_DEVIATION 8.9 • n=93 Participants
Current PAP therapy user	30 Participants n=93 Participants
Current oxygen user	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Only participants with a respiratory event index (REI) ≥ 5 events per hour according to AL were included in this analysis.

The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines.

The REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.

Outcome measures

Measure	Participants n=80 Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)	91.5 percent of agreement between AL and PSG Interval 82.8 to 100.0

SECONDARY outcome

Timeframe: Day 1

Population: Only participants with a respiratory event index (REI) ≥ 5 events per hour according to Apnealink were included in this analysis.

Total number of Obstructive events reported by the ApneaLink (AL) compared with total number of Obstructive Events reported by polysomnography (PSG). The Obstructive events of the AL are divided by the Obstructive events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825

Outcome measures

Measure	Participants n=80 Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events	0.61 Weighted Kappa statistic

SECONDARY outcome

Timeframe: Day 1

Population: Only those with an REI over to equal to 5 were included in this analysis

Total number of Central events reported by the ApneaLink (AL) compared with total number of Central Events reported by polysomnography (PSG). The Central events of the AL are divided by the Central events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825

Outcome measures

Measure	Participants n=80 Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG	0.48 Weighted Kappa statistic

SECONDARY outcome

Timeframe: Day 1

Population: Only participants with an REI above or equal to 5 were included in this analysis

The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) was calculated along with the associated one-sided 97.5% confidence interval. The positive likelihood ratio was compared with the threshold of 5 (AASM criteria for out-of-center testing devices12) using a Wald test.

Outcome measures

Measure	Participants n=80 Participants ApneaLink Air ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG
Positive Likelihood Ratio of Apnealink Air	3.7 Likelihood Ratio Interval 1.1 to 4.7

Adverse Events

Participants

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

Adam Benjafield

ResMed

Phone: +61 466 634 609

Email: adam.benjafield@resmed.com

Results disclosure agreements

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