Cognitive Training & a Healthy, Active Lifestyle Program for Patients with isolated REM-Sleep Behavior Disorder: CogTrAiL-RBD

Phase 4

Recruiting

Conditions: isolated REM sleep behavior disorder
G47.8
Other sleep disorders

Registration Number: DRKS00024898

Lead Sponsor: niversität zu Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients with iRBD:
• PSG-proven diagnosis of iRBD, which indicates a high probability for phenoconversion to Parkinson’s disease (ICD-10 G20) according to the criteria of the Movement Disorder Society (Berg et al., 2015; Heinzel et al., 2019) and the risk for developing mild cognitive impairment (ICD-10 F06.7)
• Age between 40-80 years
• Normal or corrected-to-normal vision and hearing
• German as native tongue or sufficient German language proficiency
• Sufficient computer knowledge and access to a local (laptop) computer with access to the internet

Healthy control group:
• Age between 40-80 years
• Normal or corrected-to-normal vision and hearing
• German as native tongue or sufficient German language proficiency

Exclusion Criteria

Patients with iRBD:
• Severe cognitive dysfunction (MoCA = 22)
• Limited resp. No capacity to consent
• Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder)
Additionally for those patients who consent to participate in MRI-measurement:
• Contraindications for MRI
o Objects in or at one’s body that are MRI-incompatible and indelible (e.g. neurostimulator, pacemaker, grinding work on metal)
o Big tattoos (above 20cm)
o Actual or possible pregnancy
o Fear of tight spaces

Healthy control group:
• Severe cognitive dysfunction (MoCA = 22)
• Limited resp. No capacity to consent
• Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder)
• Contraindications for MRI

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in executive functions

Secondary Outcome Measures

Name	Time	Method
Changes in a global cognition and other cognitive functions (visuo-cognition, memory, attention, working memory, language, cognitive-motoric dual-tasking);<br>Changes in the areas of depressive symptoms, health-related quality of life, subjective experience of stress, quality of sleep, non-motor and motor Parkinson-related symptoms, fine motor skills, physical activity, social and cognitive lifestyle-activities, and Mediterranean diet adherence;<br>Neuronal effects via optional structural and functional MRI and nocturnal polysomnography