Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test (STAYAWAKE)

October 23, 2024 updated by: Hospices Civils de Lyon

Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Tests Results

The predictors of objective impaired alertness assessed by Maintenance of Wakefulness Tests (MWT) are poorly understood. Identifying such predictors are essential from a clinical point of view and from a pathophysiological perspective, to better understand the determinants of residual Excessive Daytime Sleepiness (EDS) and the complex link between subjective and objective impairments.

Also, the objective of this study is to describe psychological but also sociological and professional factors associated with Maintenance of Wakefulness Tests results.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Service de Médecine du Sommeil - Hopital Croix Rousse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse)

Description

Inclusion Criteria:

  • Adult (i.e. age ≥ 18 y.o)
  • referred for Maintenance of Wakefulness test at Lyon University hospital (HCL - Croix Rousse Hospital)

Exclusion Criteria:

  • do not consent
  • unable to answer the questionary
  • cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Maintenance of Wakefulness Test
Consecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse Hospital)
Other: STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale
Patient completed STAI Scale in the 24 hours before Maintenance of Wakefulness Test during the hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI) score
Time Frame: baseline
STAI ((State-Trait Anxiety Inventory) scale is a psychological inventory of 20 self-report items on a 4-point scale. Minimum Score is 20 and maximum score is 80.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Estimated)

October 18, 2026

Study Completion (Estimated)

October 18, 2026

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0658

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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