Alteration of Cognitive FunctionHypoxiaNCT02891343
Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers
A study testing 2-hour period of hypoxia in people with Alteration of Cognitive Function and Hypoxia, run by University Hospital, Lille at 2 sites in France.
Trial summary
The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function, Hypoxia
- What is being tested?
- 2-hour period of hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2015to 31 Dec 2021
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health on the basis of the medical interview, physical examination and standard biology parameters.
- Right-Handed
- Non-smoker
- No cardiac nor pulmonary pathologies
- No use of chronic treatment or psychotropic drugs or substances
- BMI inferior to 25 Kg/m2
- French speaker and able to understand the test instructions
- Informed consent form signed
Who cannot join
- Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA)
- Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
- Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
- Subject with current chronic disease
- Subject with vascular or metabolic risk factor
- Subject with history of or current mental disease or addiction (MINI)
Show all 19Show fewer
- Subject with significant abnormality on biology
- Subject with significant abnormality on ECG
- Subject with significant abnormality on MRI
- Subject with significant abnormality of electrical activities on EEG
- Subject with family history of young onset dementia
- Subject with family history of cardiac or pulmonary pathologies
- Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
- Subject with claustrophobia or contraindication to MRI
- Subject under guardianship
- Subject not covered by Social Security
- Subject participating in another clinical trial
- Subject with anxiety (STAI-Trait Score T> 51) or neuroticism personality (EPI Score N ≥13)
- Subject bearded or refusing to shave
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'Investigation Clinique, CHRU
Lille
Centre d'investigation Clinique
Marseille
About this study
Official title: Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG
The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.
- Conditions
- Alteration of Cognitive Function, Hypoxia
- Being tested
- 2-hour period of hypoxia
- Keywords
- Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-hour period of hypoxiaOther
During this period, the FiO2 will be set on 21% (normoxia condition). A filter will be put between the mask and the tubes connecting it to the machine generating hypoxia (equipment reference = Altitrainer NP190). On that filter a gas analyser will monitor the FiO2 and a capnography monitor (Capnostream 20, ORIDION) will also be installed.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Other: 2-hour period of hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery
Measured: Between baseline (normoxic period) and Day 0 (hypoxia session )
Secondary outcomes (1)
The number of adverse events occuring during the period of hypoxia
Measured: at the baseline and after the hypoxia session (day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startNov 2015
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alteration of Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Régis Bordet, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891343
- Sponsor's protocol ID
- 2013_44
- Other IDs
- 2014-A00513-44
- Acronym
- Hypoxia
- Status last verified
- May 2026
- First submitted
- 1 Sep 2016
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG
- ClinicalTrials.gov ID
- NCT02891343
- Acronym / sponsor ID
- Hypoxia / 2013_44
- Conditions
- Alteration of Cognitive Function, Hypoxia
- Keywords
- Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Sep 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.
The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: 2-hour period of hypoxia |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Good health on the basis of the medical interview, physical examination and standard biology parameters.
- Right-Handed
- Non-smoker
- No cardiac nor pulmonary pathologies
- No use of chronic treatment or psychotropic drugs or substances
Key exclusion criteria (19 listed)
- Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA)
- Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
- Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
- Subject with current chronic disease
- Subject with vascular or metabolic risk factor
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 |
|---|---|---|
| 2-hour period of hypoxiaDuring this period, the FiO2 will be set on 21% (normoxia condition). A filter will be put between the mask and the tubes connecting it to the machine generating hypoxia (equipment reference = Altitrainer NP190). On that filter a gas analyser will monitor the FiO2 and a capnography monitor (Capnostream 20, ORIDION) will also be installed. | Other | Healthy volunteers |
Primary outcome
the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery
Time frame: Between baseline (normoxic period) and Day 0 (hypoxia session )
1 secondary outcome
The number of adverse events occuring during the period of hypoxia
Time frame: at the baseline and after the hypoxia session (day0)
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
Régis Bordet principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-hour period of hypoxia in people with Alteration of Cognitive Function and Hypoxia, run by University Hospital, Lille at 2 sites 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery (time frame: Between baseline (normoxic period) and Day 0 (hypoxia session )). 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 22 May 2026.