Monitoring des états cognitifs chez des sujets volontaires sains, sur 2 périodes, l'une avant et après administration d'une dose unique de Zolpidem, l'autre sans administration de traitement

• Conditions: It's a phase II study performed on healthy volonteers. Zolpidem (DCI) will be administered to the volunteers in order to inducing a drowsiness and a hypoattentiveness. Zolpidem is indicated in the treatment of occasional and transitory insomnia.; MedDRA version: 9.1Level: LLTClassification code 10022437Term: Insomnia

• Registration Number: EUCTR2007-001688-31-FR
• Lead Sponsor: arime company of the Mediscis group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Male subjects aged 18 to 50 years. The subjects included in the princeps study (protocol referenced 604296) are requested to take part in the present study and are firstly acceptable
2. Right-handed-person
3. Having a normal vision or corrected by contact lenses
4. Not having any known auditive deficit
5. Absence of dyslexia
6. Absence of disorders of the training in childhood having required the consulting of a speech therapist
7. Understanding the study and agreeing to sign the inform consent form
8. Communicating easily with the investigator or his representatives
9. Having faculty and agreeing to adhere to the trial constraints
10. Non smoker
11. Healthy subjects according to the medical history, the physical examination, the vital signs and the electrocardiogram at selection visit
12. Body Mass Index between 18 and 28 and body weight between 50 and 90 kg
13. Having a blood pressure and a heart rate, measured in the standard conditions at the selection visit, after at least 10 minutes in the supine position, within the following limits : systolic pressure between 90 and 140 mmHg, diastolic pressure between 50 and 90 mmHg and heart rate between 40 and 90 bpm. After 2 minutes in standing position, there should be no SBP reduction greater than 20 mmHg or DBP reduction greater than 10 mmHg associated to clinical signs
14. Having a normal ECG at the selection visit after at least 10 minutes in the supine position : PR between 120 and 210 ms, QRS = 120 ms and QTc (Bazett) = 440 ms. The Incomplete Right Bundle Branch Block will be accepted.
15. Subjects registered in French Health Ministry computerized file and authorized to participate in a clinical trial.
16. Affiliated with, or a beneficiary of, a French social security system in agreement with the French law on biomedical research (loi Huriet n° 88.1138 and its amendments)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any significant medical history or ongoing pathology being relevant (cardio-vascular, neurologic including epilepsy, hematological, hepatic, gastro-intestinal, renal, pulmonary, endocrinological, metabolic, psychiatric, cranial traumatism with loss of consciousness)
2. Colour-blind subjects
3. Subjects carrying implant or metal objects (including glasses) likely to disturb the recording system
4. Subjects having disorders of comprehension and\or reading like dyslexia, highlighted by a reading test on computer screen
5. Subjects having night-respiratory disorders (sleep apnea syndrom) highlighted by a polysomnographic recording prior to cognitive tests
6. Significant pathology during the last 2 weeks before the inclusion visit
7. Taken any type of drugs during the last 14 days preceding the first evaluation or in an interval lower or equal to 6 times drug half life
8. History of chronic alcohol consumption (> 50g per day) and/or drug abuse
9. Excessive consumption of drink containing xanthic bases (coffee, tea, cola : greater than 4 cups or glasses per day)
10. A positive urine drug screen at the selection visit and at Day -1 (opiates, cannabinoïds, cocaine, benzodiazepines, amphetamines, barbiturates)
11. Positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV antibodies
12. Frequent episodes of migraine or headaches (=once per week)
13. An inversed nycthemeral life rythm or a change of life condition during the last 48 hours preceding the first evaluation (sleepless night, night-work)
14. Subjects in the inability to sign an inform consent following linguistic or psychic problems
15. Subject who, in the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study
16. Inability to be included after checking of the National File of Volunteers (according to indemnities limited to 4500 € within 12 months and exclusion period from a previous participation to a trial).
17. In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.
18. Subject who cannot be contacted in case of emergency
19. Presence or hisory of a clinically significant medicamentous allergy
20. Zolpidem contra-indications
- Myasthenia
- Hypersensitivity in zolpidem or in one of its constituents (lactose notably)
- Obstructive sleep apnea

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize and study differences on the level of the cerebral electric activity between selective attention and diffuse attention, hypoattentiveness and drowsiness, microphone-awakening and paradoxical sleep.;Secondary Objective: Not applicable;Primary end point(s): A night 63-leads EEG recording. Night polysomnographic recording : EEG, EMG, EOG vertical and horizontal, respiratory cycle.