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

Healthy Volunteers Clinical Trial

— NoSleepDiaph  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725190
• Other study ID #: NoSleepDiaph
• Status: Completed
• Phase: N/A
• First received: March 25, 2016
• Last updated: December 8, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Diaphragm
• Healthy Volunteers
• Sleep Deprivation

Intervention

Behavioral:
• Sleepless night
Each subject will undergo 28 hours of sleep deprivation.
• Normal sleep night
Normal sleep at home before trial.

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.		The day after one normal night or one sleepless night.