Benzodiazepines DeprescribingBE-SAFENCT06584513
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
A study testing Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements in people with Benzodiazepines Deprescribing and Sleep Problems, run by Insel Gruppe AG, University Hospital Bern at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Benzodiazepines Deprescribing, Sleep Problems
- What is being tested?
- Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 18 Nov 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Switzerland1 site
Department of General Internal Medicine, University Hospital Bern (Inselspital)
Bern, 3010
About this study
Official title: Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)
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.
Read the 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% taking BSHs for sleep problems. Use of BSHs is associated with significant adverse effects such as falls, fractures, hospitalisations, impaired functioning, delirium, dementia and mortality and therefore threatens patient safety. This applies especially to older adults as they are more susceptible to adverse effects due to changes in pharmacokinetics and pharmacodynamics associated with age and to the frequent presence of polypharmacy and comorbidities.
Design:
Multicenter, superiority (first co-primary endpoint) and non-inferiority (second co-primary endpoint) cluster randomised controlled trial (RCT) conducted in six countries across Europe (Belgium, Greece Norway, Poland, Spain, and Switzerland). Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group (with training and additional material to overcome sleeping problems and to help participants discontinue BSH) or the control group (treatment according to standard of care without training or additional material). Eligible patients will be enrolled with their treating physician defined as the cluster. Outcome assessment will be blinded.
- Conditions
- Benzodiazepines Deprescribing, Sleep Problems
- Being tested
- Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physician and patient intervention | Experimental | Patients in the intervention group will be treated by physicians, who received informative and educative materials (including videos) and training, including guidelines and implementation recommendations on how to deprescribe, on shared-decision making with patients, on how to manage sleep problems using alternative methods other than BSH. Patients receive brochures and access to videos. Communication forms are implemented to ensure continuity of care. Receives: Other: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements |
| Control/Usual care | No intervention | Participants in the control group receive treatment according to standard care of the prescribing physician, who did not receive any training or additional material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSH discontinuation
Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days.
Measured: 12 months after enrollment
Quality of sleep
Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia.
Measured: 12 months after enrollment
Secondary outcomes (8)
Use of a substitute medication for sleep
Use of a substitute medication for sleep, according to self-/informal carer disclosure
Measured: 2 months, 6 months, and 12 months after enrollment
BSH discontinuation discussion with HCP
Number of patients who discussed BSH discontinuation with a HCP during the last month at M01 and M02, and during the last 4 months at M06
Measured: 1 month, 2 months, and 6 months after enrollment
Benzodiazepines (BSH) discontinuation or dose reduction
Number of patients with BSH discontinuation or dose reduction, according to self-/informal carer disclosure. Defined as the intake of a maximum of one tablet within the previous 14 days.
Measured: 2 months and 6 months after enrollment
BSH adverse events
Number of patients with adverse effects of BSHs within 12 months of follow-up, according to self/informal carer disclosure, that is:
- Falls leading to emergency room visit or hospitalisation
- Fall-related fractures leading to emergency room visit or hospitalisation. As a sensitivity analysis, facial, fingers/toes, and ankle fractures that are less likely to be osteoporotic fractures will be excluded.
- Delirium leading to emergency room visit or hospitalisation
- Hospitalisations
- Death from any cause
Measured: 12 months after enrollment
Quality of sleep
Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia.
Measured: 2 months and 6 months after enrollment
BSH standardized daily dose intake
Standardized daily dose intake based on equivalent doses for BSH (lorazepam-equivalent).
Measured: 2 months, 6 months, and 12 months after enrollment
Health-related quality of life
Health-related quality of life measured by the European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L). Consists of a visual analogue scale and short descriptive system questionnaire, corresponding to 5 severity levels of health state, higher level indicating more severe problems.
Measured: 2 months, 6 months, and 12 months after enrollment
Withdrawal symptoms from BSH discontinuation
Number of patients with withdrawal symptoms from BSH discontinuation measured by the Clinical Institute Withdrawal Assessment Scale (CIWA-B). Questionnaires composed of 20 questions, with scale that range from 0-4, which are added up to give a total score. Higher scores indicate more severe levels of withdrawal symptoms.
Measured: 2 months and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start18 Nov 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benzodiazepines DeprescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group or the control group. Patients of participating physicians will be assigned to the physician randomisation group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Oslo University Hospital, National and Kapodistrian University of Athens, Institute of Psychiatry and Neurology, Warsaw, Centre Hospitalier Universitaire UCLouvain Namur, Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Nicolas Rodondi, MD, MAS, Study chair, University Hospital Bern (Inselspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584513
- Sponsor's protocol ID
- 2024-00702
- Acronym
- BE-SAFE
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)
- ClinicalTrials.gov ID
- NCT06584513
- Acronym / sponsor ID
- BE-SAFE / 2024-00702
- Conditions
- Benzodiazepines Deprescribing, Sleep Problems
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Oslo University Hospital, National and Kapodistrian University of Athens, Institute of Psychiatry and Neurology, Warsaw, Centre Hospitalier Universitaire UCLouvain Namur, Université Catholique de Louvain
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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% taking BSHs for sleep problems. Use of BSHs is associated with significant adverse effects such as falls, fractures, hospitalisations, impaired functioning, delirium, dementia and mortality and therefore threatens patient safety. This applies especially to older adults as they are more susceptible to adverse effects due to changes in pharmacokinetics and pharmacodynamics associated with age and to the frequent presence of polypharmacy and comorbidities.
Design:
Multicenter, superiority (first co-primary endpoint) and non-inferiority (second co-primary endpoint) cluster randomised controlled trial (RCT) conducted in six countries across Europe (Belgium, Greece Norway, Poland, Spain, and Switzerland). Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group (with training and additional material to overcome sleeping problems and to help participants discontinue BSH) or the control group (treatment according to standard of care without training or additional material). Eligible patients will be enrolled with their treating physician defined as the cluster. Outcome assessment will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group or the control group. Patients of participating physicians will be assigned to the physician randomisation group.
| Arm | Type | Receives |
|---|---|---|
| Physician and patient intervention | Experimental | Other: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elementsPatients in the intervention group will be treated by physicians, who received informative and educative materials (including videos) and training, including guidelines and implementation recommendations on how to deprescribe, on shared-decision making with patients, on how to manage sleep problems using alternative methods other than BSH. Patients receive brochures and access to videos. Communication forms are implemented to ensure continuity of care. |
| Control/Usual care | No intervention | –Participants in the control group receive treatment according to standard care of the prescribing physician, who did not receive any training or additional material. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (14 listed)
- Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elementsThe 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. | Other | Physician and patient intervention |
Primary outcome
BSH discontinuation
Time frame: 12 months after enrollment
Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days.
Quality of sleep
Time frame: 12 months after enrollment
Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia.
8 secondary outcomes
Use of a substitute medication for sleep
Time frame: 2 months, 6 months, and 12 months after enrollment
BSH discontinuation discussion with HCP
Time frame: 1 month, 2 months, and 6 months after enrollment
Benzodiazepines (BSH) discontinuation or dose reduction
Time frame: 2 months and 6 months after enrollment
BSH adverse events
Time frame: 12 months after enrollment
Quality of sleep
Time frame: 2 months and 6 months after enrollment
BSH standardized daily dose intake
Time frame: 2 months, 6 months, and 12 months after enrollment
Health-related quality of life
Time frame: 2 months, 6 months, and 12 months after enrollment
Withdrawal symptoms from BSH discontinuation
Time frame: 2 months and 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Rodondi, MD, MAS study chair
University Hospital Bern (Inselspital)
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements in people with Benzodiazepines Deprescribing and Sleep Problems, run by Insel Gruppe AG, University Hospital Bern at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Greece, Norway, Poland, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSH discontinuation (time frame: 12 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.