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

Primary Purpose

Sleep Deprivation, Healthy Volunteers, Diaphragm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleepless night
Normal sleep night
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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…)

Sites / Locations

  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Normal sleep night.

Sleepless night.

Outcomes

Primary Outcome Measures

Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2016
Last Updated
December 8, 2017
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02725190
Brief Title
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
Acronym
NoSleepDiaph
Official Title
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Healthy Volunteers, Diaphragm

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Normal sleep night.
Arm Title
Group 2
Arm Type
Other
Arm Description
Sleepless night.
Intervention Type
Behavioral
Intervention Name(s)
Sleepless night
Intervention Description
Each subject will undergo 28 hours of sleep deprivation.
Intervention Type
Behavioral
Intervention Name(s)
Normal sleep night
Intervention Description
Normal sleep at home before trial.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Drouot, MD, PhD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33895822
Citation
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.
Results Reference
derived

Learn more about this trial

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

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