Obstructive Sleep Apnea
Conditions
Brief summary
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
Detailed description
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
Interventions
DEVICEApneaLink Sleep Screener
Device used to evaluate for the presence of OSA
Sponsors
ResMed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects ( greater than 18 years of age) of either gender or any race * Suspected sleep disordered breathing * Untreated sleep disordered breathing * Willingness to use AL at home within 2 days of receipt and instruction on the AL * Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test
Exclusion criteria
* Any subject requiring home oxygen therapy * Any subject currently receiving positive airway pressure therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | Simultaneous single night recording | Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suspicion of Obstructive Sleep Apnea Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 28 |
Baseline characteristics
| Characteristic | Suspicion of Obstructive Sleep Apnea |
|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 11.3 |
| Body Mass Index | 35.9 kg/m2 STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Sensitivity and Specificity
Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
Time frame: Simultaneous single night recording
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Suspicion of Obstructive Sleep Apnea | Sensitivity and Specificity | Sensitivity | 79.0 percentage |
| Suspicion of Obstructive Sleep Apnea | Sensitivity and Specificity | Specificity | 88.2 percentage |