Actively Recruiting
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-09-30
470
Participants Needed
6
Research Sites
62 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
Universitat Autonoma de Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 65 years old or older
- Use benzodiazepines or sedative-hypnotics at least 3 times per week on average during the last 3 months
- Use these medications specifically for sleep problems, as reported by the patient or caregiver
You will not qualify if you...
- Current use of these medications for alcohol withdrawal or addiction
- Diagnosed with REM sleep behavior disorder or severe non-REM parasomnias causing harm or embarrassment
- Diagnosis of epilepsy
- Active severe anxiety disorders including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, or panic disorder
- Active psychotic disorder
- Active severe depression or bipolar disorder
- Acute suicidal thoughts
- Currently tapering sleep medications with physician support
- Planned admission to palliative care within 24 hours or life expectancy less than 12 months
- Unable to give informed consent unless a proxy consents and the patient shows no disagreement
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Centre Hospitalier Universitaire CHU UCL Namur
Yvoir, Belgium, 5530
Actively Recruiting
2
National and Kapodistrian University of Athens
Athens, Greece, 10679
Actively Recruiting
3
Oslo University Hospital
Nydalen, Norway, 4950
Actively Recruiting
4
Institute of Psychiatry and Neurology
Warsaw, Poland, 02-957
Actively Recruiting
5
Universitat Autònoma de Barcelona
Barcelona, Spain, 08041
Actively Recruiting
6
Department of General Internal Medicine, University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Actively Recruiting
Research Team
N
Nicolas Rodondi, MD, MAS
CONTACT
C
Carole E Aubert, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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