HealthySLEEPERFNCT06928168
Effect of Sleep Extension in Prevention to Sleep Deprivation
A study testing Total sleep deprivation, partial sleep deprivation and Reproductibility in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Total sleep deprivation, partial sleep deprivation and Reproductibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2025to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- - Any chronic pathology.
- Working night shift.
- Having sleep disorders: score > 5 at Pittsburg Sleep Quality Index.
- Excessive sleepiness: score >10 at Epworth Sleepiness scale.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
FEASSON Léonard
Saint-Etienne, 42055
Léonard FEASSON, PhD, 04 77 12 03 83 ext. 33, leonard.feasson@univ-st-etienne.fr
Diana RIMAUD, science Doctor, 0477120467 ext. 33, diana.rimaud@chu-st-etienne.fr
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Total sleep deprivation, partial sleep deprivation, Reproductibility
- Keywords
- Sleep deprivation, Sleep extension, Endurance running, Fatigue
- Medical subject headings
- Sleep Deprivation, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total sleep deprivationOther
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.
partial sleep deprivationOther
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.
ReproductibilityOther
This group will perform an incremental running test, driven to exhaustion, after a night of total sleep deprivation twice, at least two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| REP (reproducibility). | Experimental | This group will perform an incremental running test, driven to exhaustion, after a night of total sleep deprivation twice, at least two weeks apart. Receives: Other: Reproductibility |
| PT (total sleep deprivation). | Experimental | 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. Receives: Other: Total sleep deprivation |
| PP (partial sleep deprivation) | Experimental | This group will perform an incremental running test, run to exhaustion, in :
* a control condition (usual sleep),
* a one-night total sleep deprivation condition
* a one-night total sleep deprivation condition with 5 nights of extension beforehand. The order of conditions will be randomized. Receives: Other: partial sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance over a standardized incremental running test
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.
Measured: Day 7
Secondary outcomes (10)
Reproducibility of sleep deprivation effects.
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.
Measured: Day 7
Resistance to sleep deprivation and genetic polymorphism
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
Measured: DAy 1
Fatigue (objective and subjective, )
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.
Measured: DAy 7
Fatigue (sleepiness)
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.
Measured: DAy 7
Fatigue (perception of effort)
Perceived fatigue will be rated on a 0-10 scale before and after the time limit test.
Measured: DAy 7
Motor function (running biomechanics )
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.
Measured: Day 7
Motor function (energy cost)
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.
Measured: Day 7
Cognitive function (vigilance)
Cognitive function will be assessed before, during and after exercise using Psychomotor Vigilance Task (PVT)
Measured: Day 7
Cognitive function (attention)
Cognitive function will be assessed before, during and after exercise using concentration test (sustained attention task).
Measured: Day 7
Cognitive function (inhibition)
Cognitive function will be assessed before, during and after exercise using a battery of tests including inhibition test (Go-no Go task)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start12 Jun 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928168
- Sponsor's protocol ID
- 24CH296
- Other IDs
- 2024-A02857-40
- Acronym
- SLEEPERF
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this study involves a small number of subjects and is taking place only in ST-ETIENNE