Sleep DeprivationNoSleepDiaphNCT02725190
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
A study testing Sleepless night and Normal sleep night in people with Sleep Deprivation and Healthy Volunteers, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects. 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, Diaphragm
- What is being tested?
- Sleepless night and Normal sleep night
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Dec 2017
- 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
- Male adult volunteers
- Aged 25 to 45 years
- Regularly sleeping more than 6 hours per night
- Not excessive coffee consumers (< 3 expressos / day)
- Non smokers
- Absence of respiratory, cardiac, muscular or neurological disease or diabetes
- With a neutral Horne \& Ostberg score
Who cannot join
- Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations)
- History of epilepsy or syncope during sleep deprivation
- Taking medications that interfere with sleep (antidepressants, benzodiazepines…)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.
Read the detailed description
Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.
- Conditions
- Sleep Deprivation, Healthy Volunteers, Diaphragm
- Being tested
- Sleepless night, Normal sleep 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.
Sleepless nightBehavioural
Each subject will undergo 28 hours of sleep deprivation.
Normal sleep nightBehavioural
Normal sleep at home before trial.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Normal sleep night. Receives: Behavioral: Normal sleep night |
| Group 2 | Other | Sleepless night. Receives: Behavioral: Sleepless night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.
Measured: The day after one normal night or one sleepless night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionDec 2017
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Drouot, MD, PhD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725190
- Sponsor's protocol ID
- NoSleepDiaph
- Acronym
- NoSleepDiaph
- Status last verified
- Dec 2017
- First submitted
- 25 Mar 2016
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Westphal WP, Rault C, Robert R, Ragot S, Neau JP, Fernagut PO, Drouot X. Sleep deprivation reduces vagal tone during an inspiratory endurance task in humans. Sleep. 2021 Oct 11;44(10):zsab105. doi: 10.1093/sleep/zsab105.
PubMed 33895822
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02725190
- Acronym / sponsor ID
- NoSleepDiaph / NoSleepDiaph
- Conditions
- Sleep Deprivation, Healthy Volunteers, Diaphragm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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 purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.
Detailed description
Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Behavioral: Normal sleep nightNormal sleep night. |
| Group 2 | Other | Behavioral: Sleepless nightSleepless night. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male adult volunteers
- Aged 25 to 45 years
- Regularly sleeping more than 6 hours per night
- Not excessive coffee consumers (< 3 expressos / day)
- Non smokers
Key exclusion criteria (3 listed)
- Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations)
- History of epilepsy or syncope during sleep deprivation
- Taking medications that interfere with sleep (antidepressants, benzodiazepines…)
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 |
|---|---|---|
| Sleepless nightEach subject will undergo 28 hours of sleep deprivation. | Behavioural | Group 2 |
| Normal sleep nightNormal sleep at home before trial. | Behavioural | Group 1 |
Primary outcome
Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.
Time frame: The day after one normal night or one sleepless night.
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 11 Dec 2017.
- Derived from this study: PubMed 33895822Westphal WP, Rault C, Robert R, Ragot S, Neau JP, Fernagut PO, Drouot X. Sleep deprivation reduces vagal tone during an inspiratory endurance task in humans. Sleep. 2021 Oct 11;44(10):zsab105. doi: 10.1093/sleep/zsab105.
- Individual participant dataSharing planned: Undecided
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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, MD, PhD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepless night and Normal sleep 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 3 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 11 Dec 2017. 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. 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?
Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop. (time frame: The day after one normal night or one sleepless night.). 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 NCT02725190, 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 11 Dec 2017.