I-Corps: A home-based kit for monitoring melatonin profile in insomnia patients

The broader impact/commercial potential of this I-Corps project is the development of a device to test individuals with circadian rhythm sleep disorders at home. Conventional testing, called Dim Light Melatonin Onset (DLMO) testing, is typically conducted in a laboratory by trained staff. The proposed in-home DLMO device may enable biomedical researchers to understand the circadian rhythms and related health impacts of patients otherwise unable to participate in studies.

In addition, the technology may allow for medical diagnosis of sleep disorders at high certainty, which may help the ~20% of sleep insomnia patients with circadian rhythm disorders to receive the proper treatment while eliminating months of trial-and-error sleep treatments. The project will target melatonin circadian rhythm researchers and individuals homebound due to other illness or senior patients as potential customers.

This I-Corps project is based on the development of a device for home-based Dim Light Melatonin Onset (DLMO) testing that does not require the use of trained staff. Dim Light Melatonin Onset (DLMO) is a key parameter for the diagnosis of circadian rhythm sleep disorders. Currently, the only way to accurately measure a person’s DLMO is in a sleep facility with trained staff collecting saliva samples from a patient for 6 hours before bedtime.

This is an expensive procedure and makes it impossible for individuals that cannot be in a lab for an entire evening to have their DLMO measured. The proposed device is an intelligent machine that performs the tasks of a lab technician. It allows the user to perform the saliva sample collection at home, while monitoring whether the user successfully follows the protocol.

In addition, the proposed device uses the best performing melatonin radioimmunoassay (RIA), validated via independent research studies, and the device reports the sample collection times, sample temperatures from the moment collected until returned to the researcher, and whether the participant wore blue blocking glasses as required.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.