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Charité-Dome-Study

Charité-Dome-Study - Charité-Dome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00014737
Enrollment
40
Registered
2018-06-06
Start date
2013-01-11
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

F05.0 F05.1 F05.8 F05.9 F03

Interventions

Group 1: The combined system of NCMSys and the ChD will be evaluated during a two hours application with (1h) and without (1h) the ChD in patients in the ED and on a geriatric-gerontopsychiatric ward.

Sponsors

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Dementia patients: - Age = 60 - dementia diagnosed by mini mental status test (MMST) and general deterioration scale (GDS) - with and without delir - consent of the patient or the respective keeper and the patient; Non-dementia patients: - age =18 - consent of the patient

Exclusion criteria

Exclusion criteria: Dementia patients: - missing consent - any comorbidity that not allows a flat lying in the bed (e.g. decompensated heart failure); Non-dementia patients: - acute life-threatening somatic disease (manchester triage "red") acute psychiatric disease (according to Mini International Neuropsychiatric Interview M.I.N.I. and structured clinical interview SKID for DSM-IV) - missing consent ability

Design outcomes

Primary

MeasureTime frame
Measurements of heart rate and respiratory rate by a sensor mat with and without sheltering of patients with the Charité-Dome. Measurements of acoustics and body movements by respective sensors.

Secondary

MeasureTime frame
Staff, patients, and relatives will assess effects of the combined system on patients’ wellbeing and agitation in a standardized manner. For dementia patients, staff and relatives will use the Cohen-Mansfield Agitation Inventory (CMAI), the Clinical Global Impressions (CGI), and the Observed Emotion Rating Scale (OERS). Non-dementia patients will fill out a patient evaluation form which will be used to deduce an informed and standardized evaluation sheet during the further project.

Countries

Germany

Contacts

Public ContactRajan Somasundaram

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation

rajan.somasundaram@charite.de030450552402

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 27, 2026