Data collection as part of an outpatient, telemedicine-supported sleep, movement and function monitoring

Not Applicable

• Conditions: Parkinsons's Disease, Vegetative Dysfunction; G20; Parkinson disease

• Registration Number: DRKS00017235
• Lead Sponsor: Klinik für Neurologie, Uniklinik RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Study Completion: 2020-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Known Parkinson's disease in an early stage; majority; written consent; persons who are legally competent and mentally able to follow the instructions of the staff.

Exclusion Criteria

Pregnant and breastfeeding women; persons who are accommodated in an institution by official or court orders; persons who are dependent on or employed by the investigator; simultaneous participation in a clinical trial or taken in an investigational product 30 days before the start of the project; acute pain; Influenza; Immediate (<1 week) previous major surgery or delivery; Existing severe heart failure or aortic stenosis; diagnosed Periodic Limb Movement Disorder (PLMD); Known Restless Legs Syndrome (RLS); Known Obstructive Sleep Apnea Syndrome (OSAS); Wearing an implanted electrical device (e.g. a pacemaker, neurostimulator, etc.); taken in one of the following medications less than 12 hours prior to project participation: sympatholytics and sympathomimetics (alpha and beta agonists, beta antagonists), parasympatholytics and parasympathomimetics (antidepressants, atropine), serotonin reuptake inhibitors, antihistamines, sedatives, diuretics, fludro-cortisone, midodrin, xylometazoline (Otriven ®).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polysomnography using mobile SOMNOtouch RESP equipment in the domestic environment of Parkinson's patients in the early stages of the disease. At the next morning, data are collected while carring out exercises for cardiovascular regulation. Measured parameters are: EMG, ECG, EOG, EEG, oxygen saturation, blood pressure, pulse, body position, breathing. Subsequently an electronic diary has to be filled out.

Secondary Outcome Measures

Name	Time	Method
Practicability of the mobile measuring concept for data collection in domestic environment (SOMNOtouch RESP sleep derivation, SOMNOtouch RESP test of autonomous functions, PCompanion App electronic diary).