G20 G10 K52 M06 M32.9 M35.0
Conditions
Interventions
Group 1: People with Parkinson's disease (PD), Huntington's disease (HD), inflammatory bowel disease (IBD), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (P
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - All Groups- • Age >18 years, both genders • Willing and able to comply with the study pro-tocol including the use of the digital devices and technologies • Ability to understand oral and/or written instruc-tions in relation to the study protocol and In-formed Consent in English orthe native lan-guage of the country in residence with or with-out reasonable assistance • Ability to walk independently, to sit and stand, socialise, communicate and capable of carry-ing out the various procedures proposed in the study, according to the opinion of the Investigator - Individual disorders - PD: • Clinical diagnosis of PD according to the recent criteria of the Movement Disorders Society (Postuma et al., 2015a) • Hoehn & Yahr stage I-IV • In case of severe illness: Availability of one caregiver / family member / friend that will be available to help for various study proce-dures HD: • Genetically confirmed HD (CAG repeats =40) • pre-symptomatic, prodromal (DCL 1–3) or symptomatic (DCL 4) with Shoulson-Fahn stages 1 & 2, i.e. TFC 7-13. • In case of relevant illness as judged by the in-vestigator: availability of one caregiver / family member / friend that will be available to help for various study procedures. IBD: • Established diagnosis of Ulcerative Colitis or Crohn's Disease based on the European Crohn's and Colitis Organisation –European Society of Gastrointestinal and Abdominal Radiology (ECCO-ESGAR) guideline (Maaser et al., 2019) • Diagnosis =3 months before study entry • Stratification: o Ulcerative colitis (40%) o Crohn’s disease (60%) PSS: • Established diagnosis according to the 2016 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for primary Sjögren’s syndrome (Shiboski et al., 2017) RA: • Established diagnosis according to the 2010 American College of Rheumatology (ACR)/ Eu-ropean League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis (Aletaha et al., 2010) SLE: • Established diagnosis according to the Systemic Lupus International Collaborating Clinics (SLICC) group classification criteria (Petri et al., 2012) Healthy Controls: • Prevalent healthy conditions according to the PI assessment • No neurological, respiratory, cardiac, meta-bolic or musculoskeletal disorder that seriously affect the daily activities
Exclusion criteria
Exclusion criteria: - All Groups- • Primary diagnosis of major sleep dis-orders (i.e. insomnia, obstructive sleep apnoea, central apnoea, narcolepsy and hypersomnia) • 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 and also interpretation of the digital measurements • Severe substance or ethanol abuse that may interfere with the participant's behavior, and sleep patterns according to the opinion of the Investigator. Sleep medication as part of a treatment plan is permitted. - Individual disorders - PD: • History consistent with Dementia with Lewy bodies (DLB) and atypical parkinsonian syndromes diagnosed according to accepted criteria of the Movement Disorders Society (McFarland & Hess, 2017; McKeith et al., 2017; Postuma et al.,2015b) • Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of "vascular parkinsonism" • Delusions or paranoia (MDS-UPDRS-I.4 score 4) • Severe motor fluctuations (UPDRS-IV> 10) • More than one fall per week in the last month • The patient cannot walk at all or only with another person’s assistance (MDS-UPDRS 3.10 score 4) HD: • Acute episodes of psychosis, mania and other behavioural symptoms that would prevent the progression of the study. • Other neurological disorderswhich interfere with HD symptoms and signs in the opinion of the investiga-tor. IBD: • Hospitalization within 2 weeks of study entry because of acute flare, obstruction, fistulising disease complicated by infection and/or ab-scesses • Perianal Disease only • Liver cirrhosis with or without evidence of synthetic liver dysfunction • Primary diagnosis of chronic fatigue syndrome PSS: • Primary diagnosis of chronic fatigue syndrome RA: • Primary diagnosis of chronic fatigue syndrome SLE: • Primary diagnosis of chronic fatigue syndrome Healthy Controls: • Being investigated for any of the six conditions of interest (or similar conditions as determined by the recruit-ing clinician) • Primary diagnosis of chronic fatigue syndrome or Covid-related fatigue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify and evaluate digital parameters of fatigue that reflect daily self-reported measures in a mixed disease patient population. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Identify and evaluate digital parameters of sleep quality and daytime sleepiness that reflect daily self-reported measures in a mixed disease patient population. 2) Evaluate the relationship between the digital parameters of fatigue, sleep quality, and daytime sleepiness with weekly self-reported measures in mixed disease patient population 3) Identify and evaluate digital parameters of fatigue, sleep quality, and daytime sleepiness with daily selfreported measures for individual neurodegenerative disorders and immune-mediated inflammatory diseases (possibility to explore disease-specific endpoints) 4) Estimate the Minimal Clinically Important Difference (MCID) and Participant-reported Important Difference (MPID) of digital parameters to measure changes of fatigue, sleep quality, and daytime sleepiness. 5) Assess user`s compliance and acceptance for technologies collecting digital parameters | — |
Countries
Austria, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactWalter Maetzler
Klinik für Neurologie
Outcome results
None listed