- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322276
Effects of Exercise Timing on Sleep Quality (SLEEPCORE)
June 1, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
Effects of Exercise Timing and Physical Activity Level on Sleep Quality and Body Temperature
Modern lifestyles are marked by a prevalence of sedentary behaviors and physical inactivity, which have been linked to numerous adverse health effects.
While regular physical exercise is a well-established countermeasure, exercising in the late afternoon may paradoxically disrupt deep sleep due to increased core body temperature.
Inactive and sedentary individuals, who often have impaired autonomic function compared to endurance-trained athletes, may be particularly susceptible to these negative effects, potentially resulting in compromised thermoregulation and exacerbated disruptions to deep sleep, a critical stage of sleep essential for overall recovery.
Therefore, this study aims to investigate the impact of aerobic exercise performed in the late afternoon versus morning on: 1) deep sleep and sleep onset latency; and 2) core body temperature and its autonomic regulatory mechanisms on endurance-trained and inactive-sedentary people.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
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: Frédéric ROCHE, PhD
- Phone Number: 33 0477828695
- Email: frederic.roche@univ-st-etienne.fr
Study Locations
-
-
-
Saint-Etienne, France, 42055
- Recruiting
- CHU Saint-Etienne
-
Sub-Investigator:
- David HUPIN, MD
-
Sub-Investigator:
- Léonard FEASSON, PhD
-
Sub-Investigator:
- Clément FOSCHIA, MD
-
Sub-Investigator:
- Philippe BOIRON, MD
-
Contact:
- Florian CHOUCHOU, Ph.D. student
- Phone Number: 33 4 77 12 03 04 77 12 03 83
- Email: florian.chouchou@univ-reunion.fr
-
Contact:
- Léonard FEASSON, PhD
- Phone Number: 33 4 77 12 03 04 77 12 03 83
- Email: leonard.feasson@univ-st-etienne.fr
-
Principal Investigator:
- Frédéric ROCHE, 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:
- Group "Inactive" :No regular exercise practice (inactive people that don't follow the WHO recommendations) and have sedentary behaviors
- Group "Active": Regular exercise (athletes that are specialized in aerobic exercise, with more than 300 minutes per-week over 6 months and practice at regional level).
Exclusion Criteria:
- Have sleep disorders medically diagnosed or detected by sleep forms cutoffs (clinical insomnia by ISI, severe risk of obstructive sleep apnea by Stop-Bang, bad sleep quality by PSQI.
- Have a diagnosed mental health condition requiring treatment
- Have renal, respiratory, cardiovascular or neuromuscular disease medically diagnosed.
- Be pregnant or breastfeeding
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: "Inactive-sedentary" group
inactive participants that realize 3 experimental conditions: evening exercise, morning exercise and control (no-exercise).
|
The exercise consists of running on a treadmill at 90% of maximum aerobic speed (MAS) for 30 minutes, followed by 12% increments every 5 minutes, until exhaustion (a "time-to-exhaustion" type of exercise).
|
|
Experimental: "Active" group
endurance athletes that realize 3 experimental conditions: evening exercise, morning exercise and control (no-exercise).
|
The exercise consists of running on a treadmill at 90% of maximum aerobic speed (MAS) for 30 minutes, followed by 12% increments every 5 minutes, until exhaustion (a "time-to-exhaustion" type of exercise).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of deep slow-wave sleep
Time Frame: Once a month for 3 months
|
Evaluation of the duration of deep slow-wave sleep (N3 stage) quantified by the EEG signal from polysomnography (Nox A1, Resmed®, USA).
|
Once a month for 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of core temperature
Time Frame: Once a month for 3 months
|
Assessment of core temperature until the end of the sleep period will be measured using gastrointestinal telemetric pills (eCelsius, Bodycap®, France).
|
Once a month for 3 months
|
|
Evaluation of autonomic nervous system thermoregulation
Time Frame: Once a month for 3 months
|
Evaluation of autonomic nervous system thermoregulation through time-domain (R-R intervals in ms)
|
Once a month for 3 months
|
|
Evaluation of autonomic nervous system thermoregulation
Time Frame: Once a month for 3 months
|
Evaluation of autonomic nervous system thermoregulation through frequency- domain parameters (in Hz)
|
Once a month for 3 months
|
|
Complementary sleep evaluation
Time Frame: Once a month for 3 months
|
Complementary sleep evaluation through analysis of duration of N1, N2, and REM stages (in Percentage of Total Sleep Time)
|
Once a month for 3 months
|
|
Complementary sleep evaluation
Time Frame: Once a month for 3 months
|
Complementary sleep evaluation through characteristics of slow waves present in N3 (amplitude in microvolts)
|
Once a month for 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frédéric ROCHE, PhD, Centre Hospitalier Universitaire de 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)
January 23, 2026
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
May 31, 2029
Study Registration Dates
First Submitted
November 21, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25CH122
- 2025-A00957-42 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
This study is realized only in St-Etienne university Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy Endurance Athlet
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingInfluence of Training Session Duration on Improvements in Physiological Resilience to Exercise (RED)Healthy Volunteers | Endurance ExerciseFrance
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Federação Portuguesa de FutebolRecruitingHealthy Participants | Endurance Exercise | Substrate MetabolismPortugal
-
GENCOR Lifestage SolutionsNot yet recruitingHealthy Human Volunteers | Endurance | Muscle Strength Recovery
-
Société des Produits Nestlé (SPN)UCAM universityCompletedEndurance Cycling Performance | Performance | Endurance Exercise | SupplementSpain
-
Inland Norway University of Applied SciencesCompletedHeat-suit Endurance Training | Non-heat-suit Endurance TrainingNorway
-
Centre Hospitalier Universitaire de Saint EtienneNot yet recruitingEndurance TrainingFrance
-
Azienda Ospedaliera Universitaria Integrata VeronaDr. Michele Braggio; Dr.ssa Maria Teresa Valenti; Dr.ssa Arianna Minoia; Dr. Gianluigi... and other collaboratorsCompleted
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedAerobic EnduranceBrazil
-
United States Army Research Institute of Environmental...Completed
Clinical Trials on Aerobic Exercise
-
Riphah International UniversityCompleted
-
Sultan Abdulhamid Han Training and Research Hospital...RecruitingPhysical InactivityTurkey
-
University of FloridaAmerican Psychological Foundation; Clinical & Translational Science Institute; American Psychological Association (APA)CompletedBrain ConcussionUnited States
-
Radboud University Medical CenterUniversity Hospital, Bonn; University of Dublin, Trinity College; German Sport... and other collaboratorsCompletedMild Cognitive ImpairmentNetherlands, Ireland, Germany
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanRecruitingCardiology | PsychiatryTaiwan
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
National Yang Ming UniversityUnknownKnee OsteoarthritisTaiwan
-
RenJi HospitalRecruitingST-segment Elevation Myocardial Infarction (STEMI)China
-
Federal University of PelotasMinistry of Health, BrazilUnknownHypertension | Cardiovascular Disease | Chronic Kidney Disease | Chronic Renal DiseaseBrazil
-
Bezmialem Vakif UniversityCompletedSpecific Learning DisorderTurkey