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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-etienne, France, 42055
        • Recruiting
        • FEASSON Léonard
        • Sub-Investigator:
          • Clément FOSCHIA, MD
        • Contact:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Reproductibility
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:

  • 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.
Other: Total sleep deprivation
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 :

  • 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.
Other: partial sleep deprivation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jean Monnet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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