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NCT Number: NCT04912479

Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?

This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, France

Location status: Recruiting

Location contact

Cécile McCambridge, PharmD, PhD

CONTACT

[email protected]

33-5 61 77 64 18

About this study

Despite a trivialized use of benzodiazepine (BZD) in elderly people (EP), long-term efficacy is often questioned, and treatment has to be regularly re-examined to avoid side effects. Typical intervention techniques to aid patients in reducing their dosage involve: providing information about BZD, explaining the risks associated with a chronic exposure, and tips for a successful withdrawal. In addition, the usage of a connected device may reinforce the patient's motivation by providing details on the quality of sleep and the number of steps taken (activity).

This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unassisted mobility (1/1 for the locomotion item on KATZ Activities of Daily Living scale)
  • Mini-Mental State Examination (MMSE) ≥ 20
  • With a daily consumption of benzodiazepine for more than 3 months
  • Smartphone and/or tablet with internet connection

Exclusion criteria

  • Patient under legal protection
  • Patient refuses to participate
  • Patient does not speak French

Treatment and study plan

connected watch

Device

connected watch that provide to patients with information on their sleep quality and their performed activities

Primary outcomes

  1. success to stop or reduce benzodiazepine consumption

    Time frame: 6 months

    success to stop benzodiazepine consumption (no more intake) or reduce benzodiazepine consumption (decrease in dosage of more than 25% or non-daily intake)

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile McCambridge, PharmD, PhD

CONTACT

[email protected]

33-561776418

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BENZO-E-STOP

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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