Status:
RECRUITING
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Universitat Autonoma de Barcelona
Oslo University Hospital
Conditions:
Benzodiazepines Deprescribing
Sleep Problems
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 week...
Detailed Description
Background: Use of Benzodiazepine and Sedative Hypnotics (BSHs) is one of the three overuse practices measured by the OECD. BSH use has been reported to be as high as 15-30% in older adults with 87% ...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information:
- 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
- Epilepsy (all forms, because of risk of seizures by sleep deprivation)
- Current active diagnosis of severe general or specific anxiety disorder (including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, panic disorder with or without agoraphobia)
- Current active diagnosis of psychotic disorder with or without antipsychotic medication
- Current active diagnosis of severe depression with or without major anxiety symptoms
- Current active diagnosis of bipolar disorder with or without major anxiety symptoms
- Acute suicidal ideation
- Current formal active tapering process of BSHs supported by a physician
- Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if patient dies within the next months (this criterion is relatively vague and subjective but because there is no validated prognostic score, it is justified)
- Inability to provide informed consent (e.g., because of cognitive impairment), except if a proxy can provide consent, be actively involved in the study, and patient shows no sign of disagreement
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT06584513
Start Date
November 18 2024
End Date
February 1 2026
Last Update
September 30 2025
Active Locations (6)
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1
Centre Hospitalier Universitaire CHU UCL Namur
Yvoir, Belgium, 5530
2
National and Kapodistrian University of Athens
Athens, Greece, 10679
3
Oslo University Hospital
Nydalen, Norway, 4950
4
Institute of Psychiatry and Neurology
Warsaw, Poland, 02-957