Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in neurodegenerative disorders and immune-mediated inflammatory diseases, Feasibility Study

• Conditions: G20; M05; M06; M35; M32; Parkinson disease; Seropositive rheumatoid arthritis; Other rheumatoid arthritis; Other systemic involvement of connective tissue; Systemic lupus erythematosus

• Registration Number: DRKS00021693
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-14
• Study Completion: 2021-12-31
• Results First Posted: 2022-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

MoCA score > 15, previous use of a smartphone for at least 3 months, diagnosis of one of the mentioned diseases or healthy volunteer, able to walk independently, to sit and stand, socialise, communicate and capable of carrying out the procedures proposed in the study, according to the opinion of the Investigator.

Exclusion Criteria

Primary diagnosis of major sleep disorders (i.e., insomnia, obstructive sleep apnoea, central apnoea, narcolepsy and hypersomnia); Primary diagnosis of chronic fatigue syndrome; Presence of respiratory, cardiovascular, metabolic disorders or physical traumas that required hospitalization in the 3 months preceding the study enrollment or based on severity assessed by the PI as potentially interfering with the study execution; Cognitive impairment resulting in an inability to walk or to understand the intention of the project; Diagnosis of major psychiatric disorders according to DSM5 that can affect the execution of the study; Recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months; Substance or ethanol abuse that may interfere with the patient's behavior, and sleep patterns; Diagnosis of cancer within the past 3 years, except basal or squamous skin cancer, which has been adequately treated.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint analysis for the larger follow-up study is a comparison of candidate digital endpoints (derived from the digital technologies used) against existing clinical instruments for measuring fatigue and sleep disturbance.