N/A
Completed N=81
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Source: ClinicalTrials.gov NCT00354614 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Sensitivity and Specificity — 79.0; 88.2 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity |
79.0; 88.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00354614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.