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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017235

Enrollment

Registered

2019-10-28

Start date

2019-11-29

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

Parkinsons's Disease, Vegetative Dysfunction G20

Interventions

Group 1: Ten patients in the early stages of Parkinson's disease. Recruitment from neurological practices by means of information forms and direct contact. Study information is provided at the Clinic

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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 ®).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

Germany

Contacts

Public ContactChristina Haubrich

Klinik für Neurologie, Uniklinik RWTH Aachen

haubrich@fa-zd.de+4917634385172

Outcome results

None listed

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