DRKS00027946招募中不适用
Clinical observational study on the relationship between digital and clinical parameters of fatigue and sleep disturbances in neurodegenerative disorders and immune-mediated inflammatory diseases - IDEA-FAST COS
niversitätsklinikum Schleswig-Holstein Campus Kiel0 个研究点目标入组 2,000 人开始时间: 2022年5月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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 -
- •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
- •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.
- •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%)
- •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)
- •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)
- •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
排除标准
- •- 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 -
- •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)
- •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.
- •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
- •Primary diagnosis of chronic fatigue syndrome
- •Primary diagnosis of chronic fatigue syndrome
- •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
研究者
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