NCT02725190

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

March 25, 2016

Last Update Submit

December 8, 2017

Conditions

Sleep DeprivationHealthy VolunteersDiaphragm

Outcome Measures

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.

    The day after one normal night or one sleepless night.

Study Arms (2)

Group 1

OTHER

Normal sleep night.

Behavioral: Normal sleep night

Group 2

OTHER

Sleepless night.

Behavioral: Sleepless night

Interventions

Sleepless nightBEHAVIORAL

Each subject will undergo 28 hours of sleep deprivation.

Group 2
Normal sleep nightBEHAVIORAL

Normal sleep at home before trial.

Group 1

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

Related Publications (1)

  • 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.

    PMID: 33895822DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Xavier Drouot, MD, PhD

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2016

First Posted

March 31, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations

FR(1)