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

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.

Conditions

• Benzodiazepines Deprescribing
• Sleep Problems

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.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• Institute of Psychiatry and Neurology, Warsaw

  collaborator OTHER

• CHU UCL Namur

  collaborator UNKNOWN

• Université Catholique de Louvain

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Nicolas Rodondi, MD, MAS · University Hospital Bern (Inselspital)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2026-02-01

Completion

2026-02-01

Countries

• Belgium
• Greece
• Norway
• Poland
• Spain
• Switzerland

Study Locations