Identify and evaluate digital parameters of fatigue and sleep that reflect daily self-reported measures in a mixed disease patient population.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Identify and evaluate digital parameters of fatigue that reflect daily
self-reported measures in a mixed disease patient population.
Secondary outcome
- Identify and evaluate digital parameters of sleep quality and daytime
sleepiness that reflect daily self-reported measures in a mixed disease patient
population.
- Evaluate the relationship between the digital parameters of fatigue, sleep
quality, and daytime sleepiness with weekly self-reported measures in mixed
disease patient population.
- Identify and evaluate digital parameters of fatigue, sleep quality, and
daytime sleepiness with daily self-reported measures for individual
neurodegenerative disorders and immune-mediated inflammatory diseases
(possibility to explore disease-specific end-points).
- 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.
- Assess user`s compliance and acceptance for technologies collecting digital
parameters.
Background summary
Sleep quality, sleepiness and fatigue have a large impact on physical, mental
and social well-being, which defines health. These symptoms are highly
prevalent in many diseases including Parkinson*s disease (PD), Huntington*s
Disease (HD) inflammatory bowel disease (IBD), rheumatoid arthritis (RA),
systemic lupus erythematosus (SLE) and primary Sjögren*s syn-drome (PSS) and
deemed to be very disabling by patients. Existing measures of sleep quality,
daytime sleepiness and fatigue based on subjective, self-reported measures have
many limitations for use in clinical studies and therapeutic development.
Study objective
Identify and evaluate digital parameters of fatigue and sleep that reflect
daily self-reported measures in a mixed disease patient population.
Study design
Observational study taking place in 16 centers in 10 European countries. People
with Parkinson*s disease (PD), Huntington*s Disease (HD) inflam-matory bowel
disease (IBD), rheumatoid arthritis (RA), systemic lupus er-ythematosus (SLE),
primary Sjögren*s syndrome (PSS), as well as healthy volunteers (HV) will be
included. Participants will be included for 6 months, during this period they
will need to visit the center two times and two remote visits are planned.
Participants will use during this period digital devices, which can be used in
daily life. Fatigue and sleep will be measured via questionnaires. Participants
will be asked to donate blood, urine and/or stool samples. In total, 2000
subjects will be included in the study.
Study burden and risks
We do not perceive there to be any meaningful risks associated with
participation in this study. The sensors that will be used are CE-certified,
non-invasive and operate on very low power (for wearables < 5 volt).
Arnold-Heller-Str. 3
Kiel 24105
DE
Arnold-Heller-Str. 3
Kiel 24105
DE
Listed location countries
Age
Inclusion criteria
- Age > 18 years, both genders
- Willing and able to comply with the study protocol including the use of the
digital devices and technologies
- Ability to understand oral and/or written instructions in relation to the
study protocol and Informed Consent in English or the native language of the
country in residence with or without reasonable assistance
- Ability to walk independently, to sit and stand, socialise, communicate and
capable of carrying out the various 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)
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | DRKS00027946 |
| CCMO | NL80651.078.22 |