Fatigue Investigation Using Digital Outcomes
Recruiting · NCT07783074 · Observational (researchers observe without assigning treatment) · Lead sponsor: Liliana Barrios
View the official record on ClinicalTrials.gov →What this trial is about
This study investigates objective methods to measure and monitor fatigue in patients with post-COVID-19 condition (long COVID) and multiple sclerosis (MS), and includes a group of healthy volunteers for comparison. Fatigue is a common and debilitating symptom of both conditions, but current assessment methods rely mainly on questionnaires, which can be limited by subjectivity and recall bias. The study uses a smartphone application (the FIDO app) together with wearable devices to continuously collect data on fatigue and its fluctuations during daily life, in order to evaluate the potential of digital, objective measures compared to standard assessments. Participation lasts approximately eight weeks and includes two in-person clinic visits along with a continuous data collection phase. At the initial visit, participants complete baseline assessments and questionnaires and are introduced to the study's digital tools. During the following weeks, participants wear two wearable devices continuously (24 hours a day) and use the FIDO app to complete short daily tasks (approximately 7 minutes every two days) and brief questionnaires (approximately 5 minutes per day). All participants collect a stool sample at home at weeks 4 and 8 for gut microbiome analysis, and complete the Fatigue Scale for Motor and Cognitive Functions at week 4. At the final study visit, participants repeat a subset of the baseline assessments, provide feedback on the digital technology used, and return the study devices.
Who can take part
Inclusion criteria
- Multiple Sclerosis or Long COVID
- Confirmed diagnosis of MS (by neurologist) or Long COVID (by medical doctor).
- Smartphone ownership.
- Provide written informed consent.
- Fluent in German or English.
- Inclusion Criteria Healthy:
- Smartphone ownership.
- Provide written informed consent.
- Fluent in German or English.
Exclusion criteria
- Concomitant medication affecting fatigue or ANS such as antidepressants prescribed or adjusted 1 month before the initial visit.
- Unable to provide informed consent.
- Unwilling or unable to comply with the study protocol.
- Pregnancy or lactation.
- For controls: Diagnosis of any chronic disorders or diseases that may affect fatigue or ANS.
- For MS: Additional comorbidities that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease.
- For long COVID: Additional comorbidities diagnosed prior to the first acute COVID-19 infection that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease.
Where it is running
6 locations listed.
- Neurozentrum Basel Messeturm - Basel, Basel, Switzerland
- Bellevue Medical Group - Neurozentrum Sternen / Neurozentrum Bellevue - Zurich, Canton of Zurich, Switzerland
- University of Zurich - Zurich, Canton of Zurich, Switzerland
- NeuroPraxis Zürich GmbH - Zurich, Canton of Zurich, Switzerland
- Bellevue Medical Group - Neurozentrum Seefeld - Zurich, Canton of Zurich, Switzerland
- Klinik Lengg AG - Zurich, Canton of Zurich, Switzerland