An interventional study of ApneaLink Air in Sleep-disordered Breathing, sponsored by ResMed. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by ResMed · Not applicable, Interventional, and Diagnostic
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.
The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.
Exclusion Criteria:
ApneaLink Air
Diagnostic Test: ApneaLink Air
ApneaLink Air to be used on each participant undergoing PSG
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)
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.
Time frame: Day 1
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events
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
Time frame: Day 1
Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG
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
Time frame: Day 1
Positive Likelihood Ratio of Apnealink Air
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.
Time frame: Day 1
| Milestone | Participants |
|---|---|
| Started | 130 |
| Met primary endpoint | 80 |
| Completed | 130 |
| Not completed | 0 |
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.
| percent of agreement between AL and PSG | Participants |
|---|---|
| Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) | 91.5 (82.8 to 100) |
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
| Weighted Kappa statistic | Participants |
|---|---|
| Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events | 0.61 |
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
| Weighted Kappa statistic | Participants |
|---|---|
| Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG | 0.48 |
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.
| Likelihood Ratio | Participants |
|---|---|
| Positive Likelihood Ratio of Apnealink Air | 3.7 (1.1 to 4.7) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
Baseline population included participants that were considered eligible for the primary endpoint analysis.
| Age, Continuous(years) | Participants |
|---|---|
| Mean | 53.2 ± 13.0 |
| Sex: Female, Male(Participants) | Participants |
|---|---|
| Female | 23 |
| Male | 57 |
| Ethnicity (NIH/OMB)(Participants) | Participants |
|---|---|
| Hispanic or Latino | 36 |
| Not Hispanic or Latino | 44 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 4 |
| White | 74 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Participants |
|---|---|
| United States | 80 |
| Body Mass Index(kg/m^2) | Participants |
|---|---|
| Mean | 35.1 ± 8.9 |
| Current PAP therapy user(Participants) | Participants |
|---|---|
| Count of participants | 30 |
| Current oxygen user(Participants) | Participants |
|---|---|
| Count of participants | 1 |
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