N/A
Completed N=130
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Source: ClinicalTrials.gov NCT03470493 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) — 91.5 percent of agreement between AL and PSG
Summary
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) |
91.5 | — |
| SECONDARY Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events |
0.61 | — |
| SECONDARY Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG |
0.48 | — |
| SECONDARY Positive Likelihood Ratio of Apnealink Air |
3.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03470493). 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.