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Data collection as part of a sleep, movement and function monitoring

Data collection as part of a sleep, movement and function monitoring - PCompanion Teilprojekt I

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014584
Enrollment
9
Registered
2018-04-26
Start date
2018-12-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid eye movement sleep behavior disorder (RBD)

Interventions

Group 1: Three separate groups, each consisting of 3 patients. Recruitment of individual groups is carried out in a successive manner. Each patient obtains a polysomnography using stationary (laborato

Sponsors

Klinik für Neurologie, Uniklinik RWTH Aachen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Investigated parameter: EMG, ECG, EOG, EEG, oxygen saturation, blood pressure, pulse rate, body position, respiration

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactJohannes;Christina Schiefer;Haubrich

Klinik für Neurologie, Uniklinik RWTH Aachen;Klinik für Neurologie, Uniklinik RWTH Aachen

jschiefer@ukaachen.de;haubrich@fa-zd.de+49 241 80 89630;+4917634385172

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026