- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928168
Effect of Sleep Extension in Prevention to Sleep Deprivation (SLEEPERF)
June 13, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
Effect of Sleep Extension in Prevention to Sleep Deprivation on Running Endurance Performance
The approach of a competition can be associated to a decrease in sleep duration and quality which can negatively impact athlete's performance and health (injury risk, fall, accident).
Ultra-endurance competitions even involve partial and/or total sleep deprivation over one or several nights.
Studied investigating this question suggest that endurance performance under sleep deprivation is altered, mainly because of an effect on the rate of perceived exertion (RPE), which regulates effort intensity.
One of the methods used by athletes to limit the impact of sleep deprivation in competition is to implement sleep extension in the days prior to a competition.
However, few studies have investigated the impact of sleep deprivation et its reproducibility on performance and fatigue during a prolonged running exercise, as well as the efficiency of prior sleep extension.
The importance of such a preventive measure might also depend on individual resistance to sleep deprivation, which is variable between persons and could have genetic determinants.
This aspect remains under-studied, particularly regarding the impact of sleep deprivation on physical performance.
Therefore, this study aims at investigating the effects of sleep deprivation and prior sleep extension on prolonged duration performance.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Léonard FEASSON, PhD
- Phone Number: 33 04 77 12 03 83
- Email: leonard.feasson@univ-st-etienne.fr
Study Contact Backup
- Name: Diana RIMAUD, science Doctor
- Phone Number: 33 0477120467
- Email: diana.rimaud@chu-st-etienne.fr
Study Locations
-
-
-
Saint-etienne, France, 42055
- Recruiting
- FEASSON Léonard
-
Sub-Investigator:
- Clément FOSCHIA, MD
-
Contact:
- Léonard FEASSON, PhD
- Phone Number: 33 04 77 12 03 83
- Email: leonard.feasson@univ-st-etienne.fr
-
Contact:
- Diana RIMAUD, science Doctor
- Phone Number: 33 0477120467
- Email: diana.rimaud@chu-st-etienne.fr
-
Principal Investigator:
- Léonard FEASSON, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteer who signed the written consent form.
- Man or woman.
- Aged 18-50.
- Physically active and running at least one session of more than one hour per week.
- Haven't participated in any competition in the month before the first visit.
- Not participating in any competition during the study.
- Usual sleep time between 6h-8h per night.
Exclusion Criteria:
- - Any chronic pathology.
- Working night shift.
- Having sleep disorders: score > 5 at Pittsburg Sleep Quality Index.
- Excessive sleepiness: score >10 at Epworth Sleepiness scale.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: REP (reproducibility).
This group will perform an incremental running test, driven to exhaustion, after a night of total sleep deprivation twice, at least two weeks apart.
|
This group will perform an incremental running test, driven to exhaustion, after a night of total sleep deprivation twice, at least two weeks apart.
|
|
Experimental: PT (total sleep deprivation).
This group will perform an incremental running test, conducted until exhaustion, in:
|
This group will perform an incremental running test, conducted until exhaustion, in: - a control condition (usual sleep) - a one-night condition of partial sleep deprivation - a one-night partial sleep deprivation condition with 5 nights of prior extension.
The order of conditions will be randomized.
|
|
Experimental: PP (partial sleep deprivation)
This group will perform an incremental running test, run to exhaustion, in :
|
This group will perform an incremental running test, conducted until exhaustion, in: - a control condition (usual sleep) - a one-night condition of partial sleep deprivation - a one-night partial sleep deprivation condition with 5 nights of prior extension.
The order of conditions will be randomized.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance over a standardized incremental running test
Time Frame: Day 7
|
Sporting performance, measured by the duration of exercise in a time-limited incremental effort test in running to exhaustion, i.e. the inability to maintain the imposed pace.
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reproducibility of sleep deprivation effects.
Time Frame: Day 7
|
Repeatability of sleep deprivation effects will be assessed within the REP group by comparing performance on the time limit test (in minutes) after each sleep deprivation.
|
Day 7
|
|
Resistance to sleep deprivation and genetic polymorphism
Time Frame: DAy 1
|
The influence of genetic polymorphism will be evaluated via the effects of sleep deprivation according to the genetic polymorphism of the ADORA2A, TNFα and COMT genes
|
DAy 1
|
|
Fatigue (objective and subjective, )
Time Frame: DAy 7
|
Neuromuscular fatigue will be assessed by the loss of isometric knee extensor muscle strength measured before and just after the time limit test.
To characterize the origin of neuromuscular fatigue, electrically evoked forces from peripheral nerve stimulation and electrical muscle activity (EMG) will be measured to quantify central and peripheral fatigue.
|
DAy 7
|
|
Fatigue (sleepiness)
Time Frame: DAy 7
|
Sleepiness will be assessed using the Epworth Sleepiness Scale, and perceived exertion will be rated on a Borg scale from 6 to 20 during submaximal exercise prior to the time limit test, and regularly during the test.
|
DAy 7
|
|
Fatigue (perception of effort)
Time Frame: DAy 7
|
Perceived fatigue will be rated on a 0-10 scale before and after the time limit test.
|
DAy 7
|
|
Motor function (running biomechanics )
Time Frame: Day 7
|
Motor function will be assessed during 40 minutes of submaximal exercise at an intensity corresponding to the first ventilatory threshold (SV1) preceding the time limit test.
Running biomechanics will be investigated by measuring ground reaction forces (in Newtons) using force platforms integrated into an instrumented treadmill.
|
Day 7
|
|
Motor function (energy cost)
Time Frame: Day 7
|
Motor function will be assessed during 40 minutes of submaximal exercise at an intensity corresponding to the first ventilatory threshold (SV1) preceding the time limit test.
The energy cost of running (Cr, in J/kg/m) will be quantified by measuring gas exchanges over a 5-minute period.
|
Day 7
|
|
Cognitive function (vigilance)
Time Frame: Day 7
|
Cognitive function will be assessed before, during and after exercise using Psychomotor Vigilance Task (PVT)
|
Day 7
|
|
Cognitive function (attention)
Time Frame: Day 7
|
Cognitive function will be assessed before, during and after exercise using concentration test (sustained attention task).
|
Day 7
|
|
Cognitive function (inhibition)
Time Frame: Day 7
|
Cognitive function will be assessed before, during and after exercise using a battery of tests including inhibition test (Go-no Go task)
|
Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Frédéric ROCHE, PhD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
March 28, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 15, 2025
Study Record Updates
Last Update Posted (Actual)
June 17, 2025
Last Update Submitted That Met QC Criteria
June 13, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24CH296
- 2024-A02857-40 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
this study involves a small number of subjects and is taking place only in ST-ETIENNE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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