Sleep Deprivation
Conditions
Keywords
modafinil, connexin, sleep deprivation, cognitive performance
Brief summary
Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
Interventions
DRUGPlacebo
DRUGModafinil
DRUGTHN102
Sponsors
Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
Theranexus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion Criteria: 1. Male subjects considered healthy and aged between 18 and 40 years 2. Subject with a body mass index (BMI) between 18 and 30 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained attention (PVT) | 5 hours post treatment | Mean speed at the 10 min Psychomotor vigilance test (PVT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained attention (PVT) AUC | AUC of PVT speed during TSD | AUC of speed values at the 10 min Psychomotor vigilance test (PVT) |
| Mental flexibility | 16,5 hours post treatment | Wisconsin card sorting test |
| Mental inhibition | 16,5 hours post treatment | GO-noGO |
| Working memory | 16,5 hours post treatment | 2-Back |
Outcome results
None listed