CompletedNot Applicable

Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions

116 participantsStarted 2012-02

Plain-language summary

Intervention randomized controlled open study with 2 parallel arms . The objective of this study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly living in nursing homes. It will check that the judgment of these molecules has no pejorative effect on sleep or behavior of residents and does not induce withdrawal syndrome. Two patient groups will be constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other group will continue his treatment and withdrawal will be proposed after 8 weeks by his general practitioner (delayed intervention). Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The repercussions of withdrawal on behavior will be rated by the NPI scale.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Residents aged 70 or older and institutionalized for over a month * Receiving one or more benzodiazepines and related drugs for over 30 days; * Corresponding to stop aspects of benzodiazepines and related drugs as recent best practice guidelines by the French health authority (HAS) * Signature of informed consent by the patient attended or not his guardian, the guardian or a relative; * General practitioner agreeing to adhere to recommendations. Exclusion Criteria: * psychiatric pathology, * epilepsy * end of life situation * Refusal to participate (or representative if he is unable to consent).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility: Percentage of residents exposed to benzodiazepines & related molecules (B& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B & RM

Timeframe: screening

No negative impact on sleep assessed by NPI scale

Timeframe: evolution between day 0 and week 10

No negative impact on the behavior

Timeframe: evolution between day 0 and week 10

Trial details

NCT IDNCT02715440

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Elderly trials

Plain-language summary

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: screening

No negative impact on sleep assessed by NPI scale

Timeframe: evolution between day 0 and week 10

No negative impact on the behavior

Timeframe: evolution between day 0 and week 10