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Quickstart Evaluation: Pilot Study to investigate specific distress-related physiological reactions by means of a new multi-sensor device

Quickstart Evaluation: Pilot Study to investigate specific distress-related physiological reactions by means of a new multi-sensor device - iSenDi - Pilot Study "Quickstart Evaluation"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012132
Enrollment
30
Registered
2017-04-25
Start date
2018-12-07
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

Organic brain diseases (F00, F01, F02, F03) Organic diseases requiring palliative care F00 F01 F02 F03

Interventions

Group 1: The sensory device will be fixed at the patient´s bed in his/her absence. During the bed times the device will record continuously data (for approximately 14 hours, from 18:00 until 08:00). I

Sponsors

Universitätsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent obtained from the patient or his/her legally acceptable representative (if available) according to international guidelines and local laws. 2. Either adult persons (age >/= 18 years) who due to an organic disease are inpatients of the Clinic for Palliative Care (Medical Center - University of Freiburg) or persons above 65 years who due to an organic brain disease (ICD F00-F03) are inpatients of the Clinic for Geriatric Psychiatry and Psychotherapy (Center for Psychiatry, Emmendingen), who are likely to get into a distress situation. 3. Persons with limited ability or unable to self-report their discomfort.

Exclusion criteria

Exclusion criteria: 1. Persons who demonstrate dissent regarding their participation in the clinical study. 2. Persons who are not able to provide written informed consent for which a legally acceptable representative is not available. 3. Persons whose overall condition seems not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Primary outcome of this study is the recording of sensory signals produced by distress in patients with limited ability or unable to self-report, by means of a new multi-sensory device. Simultaneous manual expert annotation of distress episodes will allow determining how far the sensory device can detect distress episodes with high specificity, distinguishing them from other emotional states.

Secondary

MeasureTime frame
Analysis of the sensory data captured by the new device during the study to develop an algorithm for the autonomous identification of distress episodes from a continuous stream of sensory information. The study will also further aim to characterize distress-associated sensor signals and to define the optimal sensor configuration enabling their detection.

Countries

Germany

Contacts

Public ContactGerhild Becker

Universitätsklinikum Freiburg, Klinik für Palliativmedizin

gerhild.becker@uniklinik-freiburg.de0761 / 270 - 95412

Outcome results

None listed

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