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NCT05964972 Clinical Trial

Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents

Fall Patients Clinical Trial

— NOCTUSAFE  

Official title:
Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05964972
Other study ID # 19-145
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 17, 2022
Est. completion date September 30, 2023

Study information
Verified date July 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 14
Est. completion date September 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Resident of the elderly nursing home (EHPAD LES ORCHIDEES). - Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during the last 12 months. - Consent of the resident or his legal representative. - Signature of informed consent - French-speaking resident. Exclusion Criteria: - Refusal to participate in the study. - Resident exclusive day faller.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Ehpad Les Orchidees Cagny

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of falls Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device. 6 month preceding and 6 month after
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