System and Method to Determine ME/CFS and Long COVID Disease Severity Using a Wearable Sensor

Objective: We present a simple parameter, calculated from a single wearable sensor, that can be used to objectively measure disease severity in people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or Long COVID.

We call this parameter UpTime.

Methods: Prior research has shown that the amount of time a person spends upright, defined as lower legs vertical with feet on the floor, correlates strongly with ME/CFS disease severity.

We use a single commercial inertial measurement unit (IMU) attached to the ankle to calculate the percentage of time each day that a person spends upright (i.e., UpTime) and number of Steps/Day.

As Long COVID shares symptoms with ME/CFS, we also apply this method to determine Long COVID disease severity.

We performed a trial with 55 subjects broken into three cohorts, healthy controls, ME/CFS, and Long COVID.

Subjects wore the IMU on their ankle for a period of 7 days.

UpTime and Steps/Day were calculated each day and results compared between cohorts.

Results: UpTime effectively distinguishes between healthy controls and subjects diagnosed with ME/CFS ($\mathbf{p = 0.00004}$) and between healthy controls and subjects diagnosed with Long COVID ($\mathbf{p = 0.01185}$).

Steps/Day did distinguish between controls and subjects with ME/CFS ($\mathbf{p = 0.01}$) but did not distinguish between controls and subjects with Long COVID ($\mathbf{p = 0.3}$).

Conclusion: UpTime is an objective measure of ME/CFS and Long COVID severity.

UpTime can be used as an objective outcome measure in clinical research and treatment trials.

Significance: Objective assessment of ME/CFS and Long COVID disease severity using UpTime could spur development of treatments by enabling the effect of those treatments to be easily measured.