Sleep-disordered Breathing
Conditions
Brief summary
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTApneaLink Air
ApneaLink Air to be used on each participant undergoing PSG
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is 18 years of age or older * Participant is willing to provide informed consent * Participant is willing to participate in all study related procedures
Exclusion criteria
* Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using) * Requires use of oxygen therapy during sleep * Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome) * Pregnant * Participant is unsuitable to participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events | Day 1 | 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 |
| Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG | Day 1 | 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 |
| Positive Likelihood Ratio of Apnealink Air | Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants ApneaLink Air
ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 13 |
| Body Mass Index | 35.1 kg/m^2 STANDARD_DEVIATION 8.9 |
| Current oxygen user | 1 Participants |
| Current PAP therapy user | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 74 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
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
Population: Only participants with a respiratory event index (REI) ≥ 5 events per hour according to AL were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) | 91.5 percent of agreement between AL and PSG |
Secondary
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
Population: Only participants with a respiratory event index (REI) ≥ 5 events per hour according to Apnealink were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events | 0.61 Weighted Kappa statistic |
Secondary
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
Population: Only those with an REI over to equal to 5 were included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG | 0.48 Weighted Kappa statistic |
Secondary
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
Population: Only participants with an REI above or equal to 5 were included in this analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants | Positive Likelihood Ratio of Apnealink Air | 3.7 Likelihood Ratio |