G20 M05 M06 M35 M32
Conditions
Interventions
Group 1: Parkinson's Disease patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, Netherlands, United Kingdom
Contacts
Public ContactWalter Maetzler
Department of Neurology, UKSH Campus Kiel,
Outcome results
None listed