Effect of Sleep Restriction on Decision Making and Inflammation

Sleep Deprivation Clinical Trial

Official title:

Effect of Sleep Restriction on Decision Making and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989741
• Other study ID #: 2012-A00399-34
• Status: Completed
• Phase: N/A
• First received: January 12, 2013
• Last updated: November 20, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy men, < 35 yr old, BMI<26, intermediate chronotype

Exclusion Criteria:

• sleep trouble, acute or chronique disease (cardiological, neurological...), women

Related Conditions & MeSH terms

• Inflammation
• Sleep Deprivation

Intervention

Other:
• Sleep restriction
4 hours sleep by night during one week

Locations

Country	Name	City	State
France	Institut de recherche biomédicale des armées	Brétigny sur Orge

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	London tower test score (décision making)	% of good score and mean response time resulting from London Tower test, assessed during baseline, sleep restriction (day 1 to day 5) and recovery (day 1 to day 3) at 10 AM	up to 3 days
Secondary	wakefulness		maintenance of wakefulness test (MWT) score observed every day during baselline, sleep restriction and recovery at 09 AM, 12 AM, 4 PM and 7 PM
Secondary	cognitive function		up to 3 days
Secondary	Inflammation		biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM