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

Recruiting

• Conditions: Huntington's disease; Inflammatory bowel disease; 10003816; 10028037

• Registration Number: NL-OMON51751
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 145

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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