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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient under legal protection

Patient refuses to participate

Patient does not speak French

Trial design

Design model

Parallel

Treatments tested in this trial

  • connected watch

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

success to stop or reduce benzodiazepine consumption

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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