Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
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 adver
| Condition(s) | Benzodiazepines Deprescribing, Sleep Problems |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * ≥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 Criteria: * 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 fo |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Locations | Yvoir, Belgium; Athens, Greece; Nydalen, Norway; Warsaw, Poland; Barcelona, Spain; Bern, Switzerland |
| Start date | 2024-11-18 |
| NCT ID | NCT06584513 |
| Official listing | https://clinicaltrials.gov/study/NCT06584513 |