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Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

NCT ID: NCT02725190

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

Detailed Description

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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

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Sleep Deprivation Healthy Volunteers Diaphragm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1

Normal sleep night.

Group Type OTHER

Normal sleep night

Intervention Type BEHAVIORAL

Normal sleep at home before trial.

Group 2

Sleepless night.

Group Type OTHER

Sleepless night

Intervention Type BEHAVIORAL

Each subject will undergo 28 hours of sleep deprivation.

Interventions

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Sleepless night

Each subject will undergo 28 hours of sleep deprivation.

Intervention Type BEHAVIORAL

Normal sleep night

Normal sleep at home before trial.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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…)
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Drouot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33895822 (View on PubMed)

Other Identifiers

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NoSleepDiaph

Identifier Type: -

Identifier Source: org_study_id