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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

Qualifiers

≥65 years old

BSH (ATC codes N05BA, N05CF, N05CD, and N03AE01) use on average ≥3 times a week during the last 3 months prior to providing informed consent, as self-reported by the patient or by the informal carer

Taking BSH for sleep problems, as self-reported by the patient or by the informal carer

Disqualifiers

Current use of BSH for alcohol withdrawal

BSH use in the context of addiction

Rapid Eye Movement (REM) sleep Behaviour Disorders

Active diagnosis of severe non-REM-related parasomnias with risk of self-damage or giving harm to others or with high frequency or social embarrassment

Trial design

Treatments tested in this trial

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

Treatment groups

470 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Universitat Autonoma de Barcelona

Collaborator

Oslo University Hospital

Collaborator

National and Kapodistrian University of Athens

Collaborator

Institute of Psychiatry and Neurology, Warsaw

Collaborator

CHU UCL Namur

Collaborator

Université Catholique de Louvain

Collaborator