Sleep DeprivationNCT03404427
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
A study testing Normal sleep night and Sleepless night in people with Sleep Deprivation and Healthy Volunteers, run by Poitiers University Hospital at 1 site in France.
Trial summary
The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Healthy Volunteers, Skeletal Muscle
- What is being tested?
- Normal sleep night and Sleepless night
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2019to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult male volunteers;
- 25 to 45 years old
- regularly sleeping more than 6 hours per night;
- no excessive consumers of coffee (<3 espressos / day);
- absence of muscular or neurological pathology ;
- with a BMI> 18 and <25 kg / m²;
- Horne and Ostberg score> 31 and <69 ;
Who cannot join
- female sex
- history of neuromuscular disease ;
- implanted metallic or electronic equipment (vascular stent, ocular implant, pacemaker ...)
- history of epilepsy, or discomfort after sleep deprivation ;
- poor sleepers (PSQI> 5);
- exercising an activity in staggered hours;
Show all 10Show fewer
- regularly performing more than 2 nights without sleep per month;
- taking drugs interfering with sleep (antidepressants, benzodiazepines ...);
- having crossed 4 time zones in the previous 4 weeks.
- current participation in another clinical research study;
Trial locations and contacts
1 site in 1 country.
About this study
The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. However, the inspiratory endurance test is associated with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is complex, both automatic and voluntary. The investigator can reproduce this results on a simpler drive.
During the execution of an exercise involving repeated contractions of the hand it is possible to record the activation of the pre-motor cortex corresponding to the phase of preparation of the movement. The amplitude of these premotor potentials is proportional to the developed motive force.
Read more
The purpose of this study is to assess the impact of sleep deprivation on the muscular endurance of non-dominant in healthy subjects.
Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing cortical pre-motor control.
Main objective: To compare the motor endurance of healthy subjects after a night's sleep and after a sleepless night.
Secondary objective: To compare the amplitude of premature cortical control at the beginning of the endurance test after a night's sleep and after a sleepless night.
- Conditions
- Sleep Deprivation, Healthy Volunteers, Skeletal Muscle
- Being tested
- Normal sleep night, Sleepless night
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal sleep nightBehavioural
Usual hours of sleep
Sleepless nightBehavioural
Total sleep deprivation the first night
| Study group | Role | What they receive |
|---|---|---|
| Normal sleep night | Sham comparator | The first endurance test is the endurance motor control test after a normal sleep night. Receives: Behavioral: Normal sleep night |
| Sleepless night | Experimental | The first endurance test is the endurance motor test after a sleepless night. Receives: Behavioral: Sleepless night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test duration
Time, in minutes, measured between the beginning of the endurance test and the end of the test, defined by the volunteer's inability to maintain a force of at least 30% of the maximum strength for 5 seconds.
Measured: 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start14 Feb 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To compare the motor endurance of healthy subjects after a normal sleep night and after a sleepless night.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Drouot, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404427
- Sponsor's protocol ID
- HANDY-SLEEP
- Status last verified
- Apr 2020
- First submitted
- 12 Jan 2018
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rault CCS, Heraud Q, Ansquer S, Ragot S, Kostencovska A, Thille AW, Stancu A, Saulnier PJ, Drouot X. Sleep Deprivation in Healthy Males Increases Muscle Afferents, Impairing Motor Preparation and Reducing Endurance. J Clin Neurophysiol. 2024 Nov 27;42(5):457-465. doi: 10.1097/WNP.0000000000001134.
PubMed 39593197
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
- ClinicalTrials.gov ID
- NCT03404427
- Acronym / sponsor ID
- HANDY-SLEEP
- Conditions
- Sleep Deprivation, Healthy Volunteers, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. However, the inspiratory endurance test is associated with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is complex, both automatic and voluntary. The investigator can reproduce this results on a simpler drive.
During the execution of an exercise involving repeated contractions of the hand it is possible to record the activation of the pre-motor cortex corresponding to the phase of preparation of the movement. The amplitude of these premotor potentials is proportional to the developed motive force.
The purpose of this study is to assess the impact of sleep deprivation on the muscular endurance of non-dominant in healthy subjects.
Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing cortical pre-motor control.
Main objective: To compare the motor endurance of healthy subjects after a night's sleep and after a sleepless night.
Secondary objective: To compare the amplitude of premature cortical control at the beginning of the endurance test after a night's sleep and after a sleepless night.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- To compare the motor endurance of healthy subjects after a normal sleep night and after a sleepless night.
| Arm | Type | Receives |
|---|---|---|
| Normal sleep night | Sham comparator | Behavioral: Normal sleep nightThe first endurance test is the endurance motor control test after a normal sleep night. |
| Sleepless night | Experimental | Behavioral: Sleepless nightThe first endurance test is the endurance motor test after a sleepless night. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- adult male volunteers;
- 25 to 45 years old
- regularly sleeping more than 6 hours per night;
- no excessive consumers of coffee (<3 espressos / day);
- absence of muscular or neurological pathology ;
Key exclusion criteria (10 listed)
- female sex
- history of neuromuscular disease ;
- implanted metallic or electronic equipment (vascular stent, ocular implant, pacemaker ...)
- history of epilepsy, or discomfort after sleep deprivation ;
- poor sleepers (PSQI> 5);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal sleep nightUsual hours of sleep | Behavioural | Normal sleep night |
| Sleepless nightTotal sleep deprivation the first night | Behavioural | Sleepless night |
Primary outcome
Test duration
Time frame: 1 hour.
Time, in minutes, measured between the beginning of the endurance test and the end of the test, defined by the volunteer's inability to maintain a force of at least 30% of the maximum strength for 5 seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 39593197Rault CCS, Heraud Q, Ansquer S, Ragot S, Kostencovska A, Thille AW, Stancu A, Saulnier PJ, Drouot X. Sleep Deprivation in Healthy Males Increases Muscle Afferents, Impairing Motor Preparation and Reducing Endurance. J Clin Neurophysiol. 2024 Nov 27;42(5):457-465. doi: 10.1097/WNP.0000000000001134.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Drouot principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal sleep night and Sleepless night in people with Sleep Deprivation and Healthy Volunteers, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test duration (time frame: 1 hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.