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Completed

NCT Number: NCT02725190

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

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

Completed

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Key information

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, 86000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Sleepless night

Behavioral

Each subject will undergo 28 hours of sleep deprivation.

Normal sleep night

Behavioral

Normal sleep at home before trial.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: NoSleepDiaph

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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