Skip to content

Mechanisms of Action of Paradoxical Responses to Zolpidem: A Multimodal Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507404-31-03
Enrollment
180
Registered
2025-01-23
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotypical volunteers (representing the general population), Patients with acquired partial/total vision impairments, Patients with Disorders of Consciousness (DoC)

Brief summary

DoC patients: Consciousness level (Coma Recovery Scale-Revised – CRS-R); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview, if the patient recovers functional communication after IMP/placebo administration), Neurotypical volunteers: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview), Patients with vision impairments: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview); Visual functions (ophthalmological testing by a neuro-ophthalmologist)

Interventions

DRUGMANNITOL
DRUGZolpidem Viatris 10 mg comprimés pelliculés

Sponsors

Universite De Liege, CHU De Liege
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
DoC patients: Consciousness level (Coma Recovery Scale-Revised – CRS-R); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview, if the patient recovers functional communication after IMP/placebo administration), Neurotypical volunteers: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview), Patients with vision impairments: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview); Visual functions (ophthalmological testing by a neuro-ophthalmologist)

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026