NarcolepsySTAYAWAKENCT06586138
Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test
An observational study of Narcolepsy and Obstructive Sleep Apnea (OSA), run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Obstructive Sleep Apnea (OSA)
- What is being tested?
- STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2024to 14 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse)
Who may be able to join
- Adult (i.e. age ≥ 18 y.o)
- referred for Maintenance of Wakefulness test at Lyon University hospital (HCL - Croix Rousse Hospital)
Who cannot join
- do not consent
- unable to answer the questionary
- cognitive impairments
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine du Sommeil - Hopital Croix Rousse
Lyon, France, 69004
About this study
Official title: 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.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea (OSA)
- Being tested
- STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale
- Keywords
- Obstructive Sleep Apnea, Maintenance of Wakefulness Test (MVT), Anxiety, Alertness, Sleepiness, Narcolepsy
- Medical subject headings
- Narcolepsy, Sleep Apnea, Obstructive, Anxiety Disorders, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scaleOther
Patient completed STAI Scale in the 24 hours before Maintenance of Wakefulness Test during the hospitalization
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Oct 2024
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586138
- Sponsor's protocol ID
- 69HCL24_0658
- Acronym
- STAYAWAKE
- Status last verified
- Jun 2026
- First submitted
- 4 Sep 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Tests Results
- ClinicalTrials.gov ID
- NCT06586138
- Acronym / sponsor ID
- STAYAWAKE / 69HCL24_0658
- Conditions
- Narcolepsy, Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive Sleep Apnea, Maintenance of Wakefulness Test (MVT), Anxiety, Alertness, Sleepiness, Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance of Wakefulness Test | – | Other: STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scaleConsecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse Hospital) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse)
Key inclusion criteria (2 listed)
- Adult (i.e. age ≥ 18 y.o)
- referred for Maintenance of Wakefulness test at Lyon University hospital (HCL - Croix Rousse Hospital)
Key exclusion criteria (3 listed)
- do not consent
- unable to answer the questionary
- cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scalePatient completed STAI Scale in the 24 hours before Maintenance of Wakefulness Test during the hospitalization | Other | Maintenance of Wakefulness Test |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy and Obstructive Sleep Apnea (OSA), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.