Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04912479

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEconnected watchconnected watch that provide to patients with information on their sleep quality and their performed activities

Timeline

Start date
2021-10-14
Primary completion
2026-02-01
Completion
2026-02-01
First posted
2021-06-03
Last updated
2024-09-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04912479. Inclusion in this directory is not an endorsement.