MedDataX Logo

Effect of Sleep Restriction on Decision Making and Inflammation

NCT ID: NCT01989741

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
* inclusion criterias: healthy subjects, men, under 35 years, BMI\<26, no sleep troubles, intermediate chronotype
* design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
* parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
* control of sleep restriction: continuous polysomnographic survey

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Deprivation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sleep restriction, decision making, wakefullness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sleep restriction

Longitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values

Group Type OTHER

Sleep restriction

Intervention Type OTHER

4 hours sleep by night during one week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep restriction

4 hours sleep by night during one week

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy men, \< 35 yr old, BMI\<26, intermediate chronotype

Exclusion Criteria

* sleep trouble, acute or chronique disease (cardiological, neurological...), women
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut de Recherche Biomedicale des Armees

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SAUVET Fabien

médecin principal (MD, PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabien SAUVET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de recherche biomédicale des armées

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut de recherche biomédicale des armées

Brétigny-sur-Orge, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Rabat A, Gomez-Merino D, Roca-Paixao L, Bougard C, Van Beers P, Dispersyn G, Guillard M, Bourrilhon C, Drogou C, Arnal PJ, Sauvet F, Leger D, Chennaoui M. Differential Kinetics in Alteration and Recovery of Cognitive Processes from a Chronic Sleep Restriction in Young Healthy Men. Front Behav Neurosci. 2016 May 23;10:95. doi: 10.3389/fnbeh.2016.00095. eCollection 2016.

Reference Type DERIVED
PMID: 27242464 (View on PubMed)

Sauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.

Reference Type DERIVED
PMID: 25932797 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-A00399-34

Identifier Type: -

Identifier Source: org_study_id