Trial Outcomes & Findings for Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA) (NCT NCT00354614)
NCT ID: NCT00354614
Last Updated: 2017-06-28
Results Overview
Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
Recruitment status
COMPLETED
Target enrollment
81 participants
Primary outcome timeframe
Simultaneous single night recording
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Suspicion of Obstructive Sleep Apnea
Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Suspicion of Obstructive Sleep Apnea
Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
|
|---|---|
|
Overall Study
Lack of Efficacy
|
28
|
Baseline Characteristics
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Baseline characteristics by cohort
| Measure |
Suspicion of Obstructive Sleep Apnea
n=53 Participants
Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
|
|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Body Mass Index
|
35.9 kg/m2
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Simultaneous single night recordingComparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
Outcome measures
| Measure |
Suspicion of Obstructive Sleep Apnea
n=53 Participants
Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
|
|---|---|
|
Sensitivity and Specificity
Sensitivity
|
79.0 percentage
|
|
Sensitivity and Specificity
Specificity
|
88.2 percentage
|
Adverse Events
Suspicion of Obstructive Sleep Apnea
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place