NCT07322276

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Nov 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

January 23, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

November 21, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

endurance athletesexercise timingsleep quality

Outcome Measures

Primary Outcomes (1)

  • Duration of deep slow-wave sleep

    Evaluation of the duration of deep slow-wave sleep (N3 stage) quantified by the EEG signal from polysomnography (Nox A1, Resmed®, USA).

    Once weekly for three weeks (day 1, day 7, day 14, day 21)

Secondary Outcomes (5)

  • Assessment of core temperature

    Once weekly for three weeks (Day 1, Day 7, Day 14, Day 21)

  • Evaluation of autonomic nervous system thermoregulation

    Once weekly for three weeks (Day 1, Day 7, Day 14, Day 21)

  • Evaluation of autonomic nervous system thermoregulation

    Once weekly for three weeks (Day 1, Day 7, Day 14, Day 21)

  • Complementary sleep evaluation

    Once weekly for three weeks (Day 1, Day 7, Day 14, Day 21)

  • Complementary sleep evaluation

    Once weekly for three weeks (Day 1, Day 7, Day 14, Day 21)

Study Arms (2)

"Inactive-sedentary" group

ACTIVE COMPARATOR

inactive participants that realize 3 experimental conditions: evening exercise, morning exercise and control (no-exercise).

Other: Aerobic Exercise

"Active" group

EXPERIMENTAL

endurance athletes that realize 3 experimental conditions: evening exercise, morning exercise and control (no-exercise).

Other: Aerobic Exercise

Interventions

The physical exercise consist of treadmill running at 65% of the maximal aerobic speed (MAP) until exhaustion (time to exhaustion exercise type).

"Active" group"Inactive-sedentary" group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Frédéric ROCHE, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This is a single-center, open-label, randomized controlled trial with two parallel crossover groups: * "Active" group * "Inactive-sedentary" group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 7, 2026

Study Start

January 23, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations