Clinical observational study on the relationship between digital and clinical parameters of fatigue and sleep disturbances in neurodegenerative disorders and immune-mediated inflammatory diseases

Recruiting

• Conditions: G20; G10; K52; M06; M32.9; M35.0; Parkinson disease; Huntington disease; Other noninfective gastroenteritis and colitis; Other rheumatoid arthritis

• Registration Number: DRKS00027946
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify and evaluate digital parameters of fatigue that reflect daily self-reported measures in a mixed disease patient population.

Secondary Outcome Measures

Name	Time	Method
1) Identify and evaluate digital parameters of sleep quality and daytime sleepiness that reflect daily self-reported measures in a mixed disease patient population.<br>2) Evaluate the relationship between the digital parameters of fatigue, sleep quality, and daytime sleepiness with weekly self-reported measures in mixed disease <br>patient population <br>3) Identify and evaluate digital parameters of fatigue, sleep quality, and daytime sleepiness with daily selfreported measures for individual neurodegenerative <br>disorders and immune-mediated inflammatory diseases (possibility to explore disease-specific endpoints)<br>4) Estimate the Minimal Clinically Important Difference <br>(MCID) and Participant-reported Important Difference <br>(MPID) of digital parameters to measure changes of fatigue, sleep quality, and daytime sleepiness.<br>5) Assess user`s compliance and acceptance for technologies collecting digital parameters