Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

NCT06584513 | Recruiting DMC

• 1 other identifier: 2024-00702
• Study Type: interventional
• Target: 470
• Locations: 6 countries
• Sites: 6

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 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

Benzodiazepines Deprescribing; Sleep Problems

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months after enrollment

Secondary Outcomes (8)

• Use of a substitute medication for sleep

  2 months, 6 months, and 12 months after enrollment

• BSH discontinuation discussion with HCP

  1 month, 2 months, and 6 months after enrollment

• Benzodiazepines (BSH) discontinuation or dose reduction

  2 months and 6 months after enrollment

• BSH adverse events

  12 months after enrollment

• Quality of sleep

  2 months and 6 months after enrollment

Study Arms (2)

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.

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.

Interventions

Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements OTHER

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.

Physician and patient intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Universitat Autonoma de Barcelona: collaborator
• Oslo University Hospital: collaborator
• National and Kapodistrian University of Athens: collaborator
• Institute of Psychiatry and Neurology, Warsaw: collaborator
• CHU UCL Namur: collaborator
• Université Catholique de Louvain: collaborator

Study Sites (6)

Centre Hospitalier Universitaire CHU UCL Namur

Yvoir, 5530, Belgium

RECRUITING

National and Kapodistrian University of Athens

Athens, 10679, Greece

RECRUITING

Oslo University Hospital

Nydalen, 4950, Norway

RECRUITING

Institute of Psychiatry and Neurology

Warsaw, 02-957, Poland

RECRUITING

Universitat Autònoma de Barcelona

Barcelona, 08041, Spain

RECRUITING

Department of General Internal Medicine, University Hospital Bern (Inselspital)

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nicolas Rodondi, MD, MAS

  University Hospital Bern (Inselspital)

  STUDY CHAIR

Central Study Contacts

Nicolas Rodondi, MD, MAS

CONTACT

+41 31 632 00 69; nicolas.rodondi@insel.ch

Carole E Aubert, MD, MSc

CONTACT

+41 31 664 24 34; caroleelodie.aubert@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessment is performed by research team blinded to the allocated intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: November 18, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NO (1); CH (1); GR (1); PL (1); BE (1)