BridgeMD
Tests treatment safety and results for Benzodiazepines Deprescribing
Official title Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
ClinicalTrials.gov ID: NCT06584513
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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...
- Taking BSH for sleep problems, as self-reported by the patient or by the informal carer
You likely can't join 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...
- Epilepsy (all forms, because of risk of seizures by sleep deprivation)
See the full eligibility criteria
- ≥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
- 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
- Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Yvoir, Belgium
- Athens, Greece
- Nydalen, Norway
- Warsaw, Poland
- Barcelona, Spain
- Bern, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yvoir, Belgium; Athens, Greece; Nydalen, Norway; Warsaw, Poland; Barcelona, Spain; Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.