Hypnotic Intake and Motor and Cognitive Performances at High Altitude
NCT02778659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2018-01-05
Summary
This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.
Conditions
- Physiology
Interventions
- DRUG
-
Zolpidem
The hypnotic will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
- DRUG
-
The placebo will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
Sponsors & Collaborators
-
Centre d'Expertise sur l'Altitude EXALT
lead OTHER
Principal Investigators
-
Pierre Bouzat, MD PhD · University Hospital, Grenoble
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-10-31
- Completion
- 2017-10-31
Countries
- France
Study Locations
More Related Trials
-
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
NCT01106859 ·Status: COMPLETED ·Phase: PHASE1
-
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
NCT00716521 ·Status: COMPLETED ·Phase: PHASE1
-
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
NCT00283790 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
NCT00380081 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants
NCT02578472 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
NCT05456152 ·Status: UNKNOWN ·Phase: PHASE3
-
Sleep and Breathing in the General Population - Chemical Stimuli
NCT04720547 ·Status: COMPLETED ·Phase: PHASE4
-
Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T
NCT01747590 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults
NCT01071889 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.
NCT06638710 ·Status: RECRUITING ·Phase: PHASE2
-
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
NCT03331042 ·Status: COMPLETED ·Phase: PHASE3
-
Self Help Program for Hypnotics Withdrawal in Insomniac Patients
NCT02720458 ·Status: COMPLETED ·Phase: NA
-
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
NCT00295386 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
NCT03536507 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
NCT00368056 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
NCT06975514 ·Status: RECRUITING ·Phase: PHASE3
-
Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly
NCT02648776 ·Status: UNKNOWN
-
Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers
NCT00368160 ·Status: COMPLETED ·Phase: PHASE1
-
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
NCT01159652 ·Status: COMPLETED ·Phase: PHASE4
-
Combined Behavioral/Pharmacological Therapy for Insomnia
NCT00044629 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
NCT03375203 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women
NCT00940550 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
NCT01243060 ·Status: COMPLETED ·Phase: NA
-
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
NCT03892902 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
NCT01896336 ·Status: COMPLETED ·Phase: PHASE4