1123 Circadian Phase Assessments from Clinical Patients Using an At-Home Self-Collection Saliva Kit

Abstract Introduction The dim light melatonin onset (DLMO) is the gold-standard for estimating sleep timing and is recognized as a reliable diagnostic tool for circadian rhythm sleep-wake disorders (CRSWD). Its assessment may help optimize treatment of various sleep disorders. The DLMO is usually assessed in a research laboratory or clinic, which presents significant barriers. Thus, there is a need to further evaluate the ecological validity of self-directed collection at home. Salimetrics, Inc. recently introduced a circadian phase assessment kit that allows for self-collection of saliva at home accompanied by laboratory assessed DLMOs. This is a preliminary report of a limited dataset identifying normal (typical) and abnormal (atypical) melatonin profiles. Methods Sleep clinic patients (N = 197) utilized one of four different protocols that varied in the number and timing of saliva collection based on their provider’s suggestion. Despite different protocols, the actual sampling protocol was performed under the same guidance for all assessments. A typical profile was determined as an expected onset (estimated ~2.5-1.5 hours before bedtime) with a baseline of 10 pg/ml and a sleep onset of 10 pg/ml. An atypical profile fell outside these parameters. Routine medication usage was also analyzed to determine if there was a correlation between melatonin modulating medications and resulting profiles. Only sex and age were recorded as the participants collected samples as part of the clinical care protocol. Results Findings indicate 22% typical profiles vs. 78% atypical profiles. With regards to medication use: 26% of typical profiles vs 19% of atypical profiles had no medications listed, 53% vs 68% used a melatonin modulator, respectively, 14% vs 54% used a psychiatric medication, 21% vs 25% used 2+ psychiatric medications, and 9% vs 14% used a melatonin supplement within 10 days of assessment. Conclusion These data corroborate earlier investigations by Burgess and colleagues and suggest that the use of a self-directed, at-home DLMO assessment is feasible and accurate. It further suggests that medication use, or an underlying psychiatric disorder can modulate melatonin secretion exaggerating the CRSWD. Data indicates that this diagnostic tool can accurately identify many clinical sleep patients with an existing CRSWD or significant sleep wake misalignment. Support (if any) Salimetrics