Circadian rhythms are internal processes that regulate our sleep-wake cycle following a ~24-hour period. Rare disorders of the circadian system occur, resulting in shifted timing of physiology compared to external environments resulting in increased risk of cardiometabolic and psychiatric disorders as well as large impacts to education, work, and social life. People with circadian rhythm sleep work disorders (CRSWD) often go undiagnosed or misdiagnosed with insomnia. The gold standard diagnostic tool analyzes the body’s natural rise of melatonin, measuring the timing of the internal clock and provide patients and health care providers with information for accurate diagnosis and treatment. This diagnostic test is currently not covered by insurance. To increase access and lower cost, we created a more flexible, accessible, and completely remote melatonin assessment. We increased accessibility by making the assay completely home based and self-directed with a kit containing all necessary components to complete the assessment. Our pilot study, with both CRSWDs patients (N=5) and controls (N=5), found that the at-home kits are reliable and produce similar results to that of a supervised, in lab test. The kit was able to verify the type of CRSWD diagnosis and use objective measures to verify testing procedure was followed.
Circadian rhythms are our internal biological ~24-hour clock. Rare disorders of the circadian system occur and result in shifted timing of our biology compared to the environment, such as shifted sleep/wake timing and resulting in greatly increased risk of depression, diabetes, and cardiovascular disease as well as large impacts to health and wellness. People with circadian rhythm disorders are often undiagnosed or misdiagnosed with insomnia and diagnostic tests are not covered by insurance. A melatonin assay is currently the gold standard test needed to obtain a diagnosis; however, it has a large out of pocket cost associated with it. Our research is aimed to eliminate the geographical and financial barriers by creating a remote, at home kit for sample collection. Through our pilot study, this kit has had major success and has enabled us to simplify the salivary sample collection method to obtain the collections needed for accurate data for diagnosis. Between the materials, instructional videos, 24-hour access to study materials and a study staff member on call to help them during their sample collections, the results mimic those of a supervised, in hospital and/or laboratory study without the barriers of cost, wait time, and travel restrictions.
Empower and educate CRSWD patients by providing them with educational resources and a personalized study report so that they go into their appointment with knowledge. We are eliminating monetary, geographical, and scheduling inconveniences that come with getting a diagnosis.