Performance Evaluation of a Novel Screening Tool for Depressive Episodes in COMISA: A Comparative Comparison with Standard Neuropsychometric Assessments

Archie Defillo^1*Massimiliano Grassi^1,2,3Silvia Daccò^1,2,3,4Jennifer L Martin⁵Daniela Caldirola^2,3,4Giampaolo Robert Perna^2,3,4

• ¹Clinical Research and Development Department, Medibio Limited, Savage, MN, United States
• ²Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
• ³Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Hermanas Hospitalarias, Albese con Cassano, Italy
• ⁴Personalized Medicine Center for Anxiety and Panic Disorders, Humanitas San Pio X Hospital, Milan, Italy
• ⁵VA Greater Los Angeles Healthcare System, University of California, Los Angeles, CA, United States

Insomnia and obstructive sleep apnea (OSA) are each linked to elevated risks of depression. When comorbid (COMISA), these risks increase further, highlighting the need for effective depression screening. This study evaluated the screening accuracy of a novel software, MEB-001, for detecting current major depressive episode (cMDE) in individuals identified as with and without suspected COMISA (sCOMISA). Methods We conducted a retrospective sub-analysis from a prospective multicenter study at U.S. sleep clinics, including 296 adults who underwent routine polysomnography (PSG). Electrocardiogram and electroencephalogram signals, along with items 1 and 2 of the self-report depression screener Patient Health Questionnaire, 9 items (PHQ-9), were used to generate MEB-001 screening output. The Mini International Neuropsychiatric Interview (MINI) served as the diagnostic reference for cMDE. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for MEB-001 and PHQ-9 (cut-off ≥10), with subgroup comparisons conducted using Fisher’s exact and McNemar’s tests (p < 0.05). Results MINI identified cMDE in 15.5% of participants (16.9% in sCOMISA; 14.2% in non-COMISA). Against the MINI, MEB-001 achieved 84.8% sensitivity, 72.0% specificity, 35.8% PPV, and 96.3% NPV in the full cohort; PHQ-9 ≥10 showed similar performance (89.1%, 68.4%, 34.2%, and 97.2%, respectively). MEB-001's performance did not differ between sCOMISA and non-sCOMISA (all p ≥ 0.68), and no significant McNemar differences were found in the subgroups (p > 0.19). Conclusions MEB-001 demonstrated consistent cMDE screening performance comparable to the PHQ-9, supporting its potential utility in sleep clinic settings.