Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06584513
NA

Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.

Official title: Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

470

Start Date

2024-11-18

Completion Date

2026-02-01

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

OTHER

Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements

The intervention consists of a patient-centred intervention to help patients in deprescribing BSHs and better managing their sleep problems. The material used consists of training modules, brochures, and self-monitoring tools. There are materials for physicians and for patients.

Locations (6)

Centre Hospitalier Universitaire CHU UCL Namur

Yvoir, Belgium

National and Kapodistrian University of Athens

Athens, Greece

Oslo University Hospital

Nydalen, Norway

Institute of Psychiatry and Neurology

Warsaw, Poland

Universitat Autònoma de Barcelona

Barcelona, Spain

Department of General Internal Medicine, University Hospital Bern (Inselspital)

Bern, Switzerland