The objective is to find the most promising digital / objective sleep and fatigue parameters, which can be assessed with digital technologies in the home environment.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Digital measures with best correlations with the patient-reported measures of
sleep disturbances and fatigue as well as the clinical outcome measures will be
considered for further investigations in the subsequent larger study (part B,
not included in this proposal).
Secondary outcome
Na
Background summary
Existing measures of sleep disturbances and fatigue based on subjective,
self-reported measures have many limitations for use in clinical studies and
therapeutic development. Objective measures are either not available or in the
case of sleep, are expensive and labour intensive (polysomnography) and are
inconvenient to the patients. Furthermore, existing measures are unsuitable for
use in ecological settings. This observational study aims to define the most
useful objective parameters for sleep disturbances and fatigue, as assessed
with home-based / mobile digital devices in patients suffering from PD, HD,
IBD, PSS, RA or SLE, as sleep disturbances and fatigue are prevalent and
burdensome in these diseases.
Study objective
The objective is to find the most promising digital / objective sleep and
fatigue parameters, which can be assessed with digital technologies in the home
environment.
Study design
The study (part A of the IDEA-FAST project) has an exploratory design, and thus
does not focus on a *single* primary outcome measure. Our primary goal,
however, is to identify promising digital measurements (endpoints) of sleep
disturbances and fatigue that can be used in the ecological settings. This goal
will be achieved by comparing measures collected through novel digital tools
with traditional i) clinical outcomes (e.g., surveys) and ii) patient-reported
outcomes (questionnaires and diaries). Digital measures with best correlations
with the patient-reported measures of sleep disturbances and fatigue as well as
the clinical outcome measures will be considered for further investigations in
the subsequent larger study (part B, not included in this proposal). A sample
of 180 participants will be recruited across the four sites to represent the
disease cohorts of interest in IDEA-FAST.
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.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years, both genders
• Anticipated availability for using multiple study devices over the period of
60 days, with appropriate breaks within this period.
• Willingness to comply with the study protocol including the use of the
digital devices and technologies.
• Previous use of a smartphone for at least 3 months.
• 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.
• Willingness to sign the IRB-approved Informed Consent Form (ICF) having had
enough time and opportunity to think about his/her participation in the study.
• 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.
• MoCA > 15
For IBD patients
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 [9].
• Diagnosis >=3 months before study entry
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.
• Close affiliation with the investigational site (e.g. employee or student of
the investigational site)
• Diagnosis of cancer within the past 3 years, except basal or squamous skin
cancer, which has been adequately treated.
• Visual impairment, as judged by the investigator
For IBD patients
• • No 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 [9].
• Diagnosis <3 months before study entry
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 |
|---|---|
| CCMO | NL73780.078.20 |