NCT06928168

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
22mo left

Started Jun 2025

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jun 2025Mar 2028

First Submitted

Initial submission to the registry

March 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

March 28, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

Sleep deprivationSleep extensionEndurance runningFatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 7

Secondary Outcomes (10)

  • Reproducibility of sleep deprivation effects.

    Day 7

  • Resistance to sleep deprivation and genetic polymorphism

    DAy 1

  • Fatigue (objective and subjective, )

    DAy 7

  • Fatigue (sleepiness)

    DAy 7

  • Fatigue (perception of effort)

    DAy 7

  • +5 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: partial sleep deprivation

Interventions

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.

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.

PP (partial sleep deprivation)

This group will perform an incremental running test, driven to exhaustion, after a night of total sleep deprivation twice, at least two weeks apart.

REP (reproducibility).

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Any chronic pathology.
  • Working night shift.
  • Having sleep disorders: score \> 5 at Pittsburg Sleep Quality Index.
  • Excessive sleepiness: score \>10 at Epworth Sleepiness scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FEASSON Léonard

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sleep DeprivationFatigue

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Frédéric ROCHE, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana RIMAUD, science Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 15, 2025

Study Start

June 12, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

this study involves a small number of subjects and is taking place only in ST-ETIENNE

Locations