This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
306
The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Delta Waves, Inc.
Colorado Springs, Colorado, United States
Florida Lung and Sleep Associates
Lehigh Acres, Florida, United States
Pulmonary and Critical Care Association of Baltimore
Towson, Maryland, United States
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time frame: Visit 2 (within six weeks of enrollment)
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time frame: Visit 2 (within six weeks of enrollment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clayton Sleep Institute
Maplewood, Missouri, United States
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States