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

NCT06586138 | Completed

• 1 other identifier: 69HCL24_0658
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcolepsy; Obstructive Sleep Apnea (OSA)

Keywords

Obstructive Sleep Apnea; Maintenance of Wakefulness Test (MVT); Anxiety; Alertness; Sleepiness; Narcolepsy

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory (STAI) score

  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

Study Arms (1)

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

Interventions

STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale OTHER

Patient completed STAI Scale in the 24 hours before Maintenance of Wakefulness Test during the hospitalization

Maintenance of Wakefulness Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine du Sommeil - Hopital Croix Rousse

Lyon, France, 69004, France

Location

MeSH Terms

Conditions

Narcolepsy; Sleep Apnea, Obstructive; Anxiety Disorders; Sleepiness

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 18, 2024
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

FR (1)