PhysiologyCHAMNCT02778659
Hypnotic Intake and Motor and Cognitive Performances at High Altitude
A study testing Zolpidem in people with Physiology, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No sojourn above 2500 m during the past 2 months
- Coffee intake < 3 cups per day
- Non-smoker
Who cannot join
- Respiratory, cardiovascular, metabolic or neuromuscular diseases
- Psychiatric disorders
- Use of hypnotics within the past year
- Dependence syndrome (alcool, drugs, etc)
- Severe insomnia or somnolence
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, 38043
About this study
Official title: The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
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
- Being tested
- Zolpidem, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem Normoxia | Experimental | Acute zolpidem intake at sea level Receives: Drug: Zolpidem |
| Placebo Normoxia | Sham comparator | Acute placebo intake at sea level Receives: Drug: Placebo |
| Zolpidem Hypoxia | Experimental | Acute zolpidem intake at high altitude Receives: Drug: Zolpidem |
| Placebo Hypoxia | Sham comparator | Acute placebo intake at high altitude Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance assessed using Simon cognitive test
Simon cognitive test
Measured: 4 hours after drug/placebo intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Bouzat, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778659
- Sponsor's protocol ID
- CHAM
- Acronym
- CHAM
- Status last verified
- Jan 2018
- First submitted
- 18 May 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
- ClinicalTrials.gov ID
- NCT02778659
- Acronym / sponsor ID
- CHAM / CHAM
- Conditions
- Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALTUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zolpidem Normoxia | Experimental | Drug: ZolpidemAcute zolpidem intake at sea level |
| Placebo Normoxia | Sham comparator | Drug: PlaceboAcute placebo intake at sea level |
| Zolpidem Hypoxia | Experimental | Drug: ZolpidemAcute zolpidem intake at high altitude |
| Placebo Hypoxia | Sham comparator | Drug: PlaceboAcute placebo intake at high altitude |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No sojourn above 2500 m during the past 2 months
- Coffee intake < 3 cups per day
- Non-smoker
Key exclusion criteria (5 listed)
- Respiratory, cardiovascular, metabolic or neuromuscular diseases
- Psychiatric disorders
- Use of hypnotics within the past year
- Dependence syndrome (alcool, drugs, etc)
- Severe insomnia or somnolence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemThe 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 | Zolpidem Hypoxia, Zolpidem Normoxia |
| PlaceboThe 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. | Drug | Placebo Hypoxia, Placebo Normoxia |
Primary outcome
Cognitive performance assessed using Simon cognitive test
Time frame: 4 hours after drug/placebo intake
Simon cognitive test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Bouzat, MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolpidem in people with Physiology, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance assessed using Simon cognitive test (time frame: 4 hours after drug/placebo intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.