Sleep and fatigue assessment in the home environment with digital technology

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 28

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