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
Among 21 studies in Sleep Apnea Syndromes by ResMed — none open to participants now, none under way, none of them phase 3. Sleep Apnea Syndromes · ResMed.
Among the 21 studies in Sleep Apnea Syndromes by ResMed, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 12 with no phase, and was the 20th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
Browse Sleep Apnea Syndromes studies →None of the 21 studies in Sleep Apnea Syndromes by ResMed is open now.
Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
This study's enrollment of 130 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Median enrollment 50 across the 13 interventional studies, 678 across the 8 observational. Of the 20 that completed or were terminated, 10 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Sleep Apnea Syndromes by ResMed, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Mar 2019, 10 months.
Results were first posted in May 2021, 2 years 2 months after primary completion.
Of 68 industry-sponsored interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 10 months is close to that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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