Effect of Hypoxia on Cognitive Assessment and Cerebral Ac... | NCT02891343

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

NCT02891343

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

May 22, 2026Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Alteration of Cognitive Function
Hypoxia

Interventions

2-hour period of hypoxia

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A00513-44	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor decision

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 1, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers	Experimental		Other: 2-hour period of hypoxia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2-hour period of hypoxia	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery		Between baseline (normoxic period) and Day 0 (hypoxia session )

Secondary Outcomes

Measure	Description	Time Frame
The number of adverse events occuring during the period of hypoxia		at the baseline and after the hypoxia session (day0)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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)
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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation Clinique, CHRU		Lille			France
Centre d'investigation Clinique

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms