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Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers (Hypoxia)

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ClinicalTrials.gov Identifier: NCT02891343
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Alteration of Cognitive Function Hypoxia Other: 2-hour period of hypoxia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG
Actual Study Start Date : November 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy volunteers Other: 2-hour period of hypoxia
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.




Primary Outcome Measures :
  1. 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 ) ]

Secondary Outcome Measures :
  1. The number of adverse events occuring during the period of hypoxia [ Time Frame: at the baseline and after the hypoxia session (day0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA)
  2. Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
  3. Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
  4. Subject with current chronic disease
  5. Subject with vascular or metabolic risk factor
  6. Subject with history of or current mental disease or addiction (MINI)
  7. Subject with significant abnormality on biology
  8. Subject with significant abnormality on ECG
  9. Subject with significant abnormality on MRI
  10. Subject with significant abnormality of electrical activities on EEG
  11. Subject with family history of young onset dementia
  12. Subject with family history of cardiac or pulmonary pathologies
  13. Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
  14. Subject with claustrophobia or contraindication to MRI
  15. Subject under guardianship
  16. Subject not covered by Social Security
  17. Subject participating in another clinical trial
  18. Subject with anxiety (STAI-Trait Score T> 51) or neuroticism personality (EPI Score N ≥13)
  19. Subject bearded or refusing to shave

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891343


Contacts
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Contact: Régis Bordet, MD,PhD regis.bordet@univ-lille2.fr

Locations
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France
Centre d'Investigation Clinique, CHRU Not yet recruiting
Lille, France
Principal Investigator: Elsa Jozefowicz, MD         
Centre d'investigation Clinique Recruiting
Marseille, France
Principal Investigator: Christine Audebert, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Régis Bordet University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02891343    
Other Study ID Numbers: 2013_44
2014-A00513-44 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
Cognitive Function
Hypoxia
Neurophysiological Function
Effect of Alzheimer Disease symptomatic drugs
Healthy Subjects
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory