Helping older adults safely manage sleep problems without sleeping pills

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)

This study is testing a new way to help older adults manage their sleep problems without using sleeping pills, by combining a tapering plan with education and therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 470 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 6 sites (Yvoir and 5 other locations)
• Trial ID: NCT06584513 on ClinicalTrials.gov

What this trial studies

This study aims to improve patient safety among older adults by testing a patient-centered intervention designed to reduce the use of benzodiazepines and other sedative-hypnotics for sleep problems. Conducted as a multicenter, randomized controlled trial across six European countries, the intervention includes a specific tapering plan for sleep medication along with educational and cognitive behavioral therapy elements. Physicians will be randomly assigned to either the intervention group, which receives training and additional resources, or the control group, which follows standard care. The study will assess outcomes while keeping participants unaware of their group assignments to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 65 and above who have been using sleeping pills at least three times a week for sleep problems.

Not a fit: Patients who are currently using sleeping pills for conditions where discontinuation could be dangerous, such as alcohol withdrawal or severe anxiety disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the safety and quality of life for older adults by reducing reliance on potentially harmful sleep medications.

How similar studies have performed: Other studies have indicated that interventions aimed at reducing benzodiazepine use in older adults can be effective, suggesting that this approach has potential for success.

Eligibility criteria

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 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

Where this trial is running

Yvoir and 5 other locations

• Centre Hospitalier Universitaire CHU UCL Namur — Yvoir, Belgium (Recruiting)
• National and Kapodistrian University of Athens — Athens, Greece (Recruiting)
• Oslo University Hospital — Nydalen, Norway (Recruiting)
• Institute of Psychiatry and Neurology — Warsaw, Poland (Recruiting)
• Universitat Autònoma de Barcelona — Barcelona, Spain (Recruiting)
• Department of General Internal Medicine, University Hospital Bern (Inselspital) — Bern, Switzerland (Recruiting)

Study contacts

• Study coordinator: Nicolas Rodondi, MD, MAS

Conditions Benzodiazepines Deprescribing; Sleep Problems