Data collection as part of a sleep, movement and function monitoring
- Conditions
- Rapid eye movement sleep behavior disorder (RBD)
- Registration Number
- DRKS00014584
- Lead Sponsor
- Klinik für Neurologie, Uniklinik RWTH Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 7
Known REM sleep behavioral disorder; age of majority; signed declaration of consent; persons who are capable and mentally able to follow the instructions of the study staff
Pregnant and breastfeeding women; Minority; Acute pain; Flu infections; Existing diarrhea; Previous (less than a week) surgery or childbirth; Existing severe heart failure or aortic stenosis; intake of one of the following medications less than 12 hours before study participation: Sympatholytics and sympathomimetics, parasympatholytics and parasympathomimetics, inhibitors for serotonin reuptake, antihistamines, sedatives, diuretics, fludrocortisone, midodrine, xylometazoline (Otriven ®); Periodic Limb Movement Disorder (PLMD); Restless-Legs-Syndrom (RLS); sleep apnea syndrome (OSA); carrying an implanted electrical device (e.g. pacemaker or neurostimulator); intake of meal, coffee, tea, coke, tobacco, alcohol less than 3 hours prior to study participation;
persons who are accommodated in an institution due to an official or court related order; persons in dependency or employment relationship with the participating physician; simultaneous participation in another clinical trial; patients who are unwilling or unable to understand and follow the instructions given by the medical staff; persons which are incapable of giving their consent for study participation and/or are unable to understand the nature, significance and scope of the project and therefore are incapable to give their consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative polysomnography using stationary (laboratory in hospital) and mobile (SOMNOtouch RESP) measuring equipment over night; comparative functional diagnostics using stationary and mobile measuring equipment afterwards.<br>Investigated parameter: EMG, ECG, EOG, EEG, oxygen saturation, blood pressure, pulse rate, body position, respiration<br>
- Secondary Outcome Measures
Name Time Method Comparative investigation of suitability and quality of stationary and mobile measuring equipment to obtain Parkinson’s disease specific data - within 8 weeks after study participation; evaluation of usability of the mobile measuring equipment by obtaining patient and user feedback (questionnaires to be completed) directly after vegetativum examination.