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Mechanisms of Action of Paradoxical Responses to Zolpidem: A Multimodal Study
EU CTIS ID: 2023-507404-31-03
What this study is testing
This clinical trial aims to investigate the potential underlying mechanisms of action of zolpidem in three groups of patients with disorders of consciousness (DoC), neurotypical volunteers representing the general population, and patients with partial/total acquired vision impairments as certain proportion of people in all these groups respond paradoxically to zolpidem. Paradoxical responses to zolpidem lead to recovery of consciousness in DoC patients and temporary recovery of vision in patients with vision impairments. Neurotypical volunteers with paradoxical responses also show inability to fall asleep, higher levels of concentration, increased agitation, etc. Therefore, the findings of this study could contribute to a better understanding of the mechanisms of action of zolpidem in paradoxical responders vs. non-paradoxical responders to zolpidem and can lead to improved personalised patient care.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- DoC patients: >18 years old; >28 days post-injury; diagnosis of UWS, MCS-, MCS+ or EMCS according to international guidelines and behavioural assessments with CRS-R; stable vital parameters; no neurological deficits prior to brain injury; signed consent form (by the patient if capable of giving informed consent or by the patient’s legal guardian). All patients will be observed at least one week prior to intervention to establish their baseline clinical profile.
- Neurotypical volunteers: ≥18 years of age; no psychiatric/neurological disorders at the time of inclusion; a good state of health; negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) for WOCBP* within 24 hours prior to the start of the CT; WOCBP and male participants who are sexually active with WOCBP must agree to follow method(s) of contraception from 48 hours before the start of the trial until 24 hours (>4 half-life of zolpidem) after the termination of the trial; signed consent form.
- Patients with vision impairments: ≥18 years of age; acquired total/partial vision impairments documented following relevant testing by a neuro-ophthalmologist; no psychiatric/neurological disorders at the time of inclusion; negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) for WOCBP within 24 hours prior to the start of the CT; WOCBP and male participants who are sexually active with WOCBP must agree to follow method(s) of contraception from 48 hours before the start of the trial until 24 hours (>4 half-life of zolpidem) after the termination of the trial; signed consent form.
You likely can't join if
- DoC patients: Use of ketoconazole, fluvoxamine, and/or ciprofloxacine in the last 7 days or 4 half-lives of the drug before the initiation of the experiment; use of zolpidem in the last 24 hours before the start of any phase of the study; contraindications to EEG (e.g., skin sensitivity).
- Neurotypical volunteers: Use of ketoconazole, fluvoxamine, and/or ciprofloxacine in the last 7 days or 4 half-lives of the drug before the initiation of the experiment; use of zolpidem in the last 24 hours before the start of any phase of the study; contraindications to EEG (e.g., skin sensitivity); breastfeeding (women), pregnancy (women).
- Patients with vision impairments: Use of ketoconazole, fluvoxamine, and/or ciprofloxacine in the last 7 days or 4 half-lives of the drug before the initiation of the experiment; use of zolpidem in the last 24 hours before the start of any phase of the study; contraindications to EEG (e.g., skin sensitivity); breastfeeding (women), pregnancy (women).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.