An interventional study of Total sleep deprivation and Normal sleep in Sleep Deprivation, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Basic science
This study aims at measuring the impact of a night of sleep deprivation over the vocal characteristics of healthy subjects.To do so, the subjects takes a Multiple Sleep Latency Test (MSLT) the day after a night of total sleep deprivation (or a supervised normal night for the control subjects). Before each iteration of the MSLT, the subjects are recorded during the reading of a text and fill three medical questionnaires : Karolinska Sleepiness Scale (KSS), Visual Analogue Scale for Fatigue (VAS-F) and Visual Analogue Scale for Anxiety (VAS-A), allowing to link variations of vocal markers to the variations of these measures.
Excessive Daytime Sleepiness (EDS) is a frequent symptom that concerns between 5% and 8% of the population. The individual consequence of EDS is a diminution of the life quality. Furthermore, EDS is a cause of high socio-medical costs though the accidental risks that it induces at work and on the road (Ohayon, Reynolds et al. 2013). Indeed, it is a severe symptom due to the consequences that it is the cause of. Furthermore, EDS is associated to 5 to 20% of road accidents depending on the type of road network. As a consequence, to elaborate a sleepiness detection through voice in real time system is a major challenge for public health-care and medicine. Moreover, it offers benefits from a socio-medical aspect, as detecting sleepiness through voice doesn't require neither consumables furniture nor specialized staff to be set up.
To highlight the effect of sleepiness over voice, investigators designed this experiment around a night of total sleep deprivation. To measure objective sleepiness of subjects, they takes a MSLT test the day after a night of total sleep deprivation (or a supervised night for control). The complementary measures (KSS, VAS-A, VAS-F and Psychomotor Vigilance Task (PVT)) will allow to study the exact origin of the variations of the vocal markers induced by the sleep deprivation.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
higher ou equal performances than 25th percentile for performances assessed in total population for the following tasks : " lecture de " l'Alouette " " (Number of correctly read words / minute ≥ 121, number of errors ≤ 10), isolated words reading (regular words : score ≥ 18, time ≤ 17 sec ; irregular words : score ≥ 16, time ≤ 16 sec, pseudo-words : score ≥ 17, time ≤ 26 sec), repetition of non-words (score ≥ 19), and symbol crossing task (number of crossed symbols ≥ 22),
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants enrolled in this arm will have a total sleep deprivation on their first experimental visit and a normal sleep on their second experimental visit.
Other: Total sleep deprivation · Other: Normal sleep
The participants enrolled in this arm will have a normal on their first experimental visit and a total sleep deprivation sleep on their second experimental visit.
Other: Total sleep deprivation · Other: Normal sleep
Participants will perform repeatedly : task of reading with voice acquisition before each MSLT, KSS, VAS-Anxiety, VAS-Fatigue and PVT during the day after a night of total sleep deprivation.
Participants will perform repeatedly : task of reading with voice acquisition before each MSLT, KSS, VAS-Anxiety, VAS-Fatigue and PVT during the day after a night of normal sleep.
Acoustic fingerprint
Acoustic fingerprint (statistics on prosody, frequency and energy) influenced by sleep deprivation measured at each iteration of TILE at visits V2 and V3.
Time frame: Visit 3 (V3) between 14 and 60 days after inclusion (V1)
sleep onset
The sleep onset at each iteration of the MSLT (in minutes). This evaluate the objective sleepiness of the subject, right after that its voice has been recorded, allowing to link vocal markers and objective sleepiness of the subject.
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Karoslinska Sleepiness Scale questionnaire
The score to the Karoslinska Sleepiness Scale questionnaire. This measure links the vocal markers with subjective instantaneous sleepiness. Minimum value 1 (extremely alert); maximum value 9 (extremely sleepy, fighting sleep)
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
VAS-Fatigue
The score to the VAS-Fatigue. This measure links the vocal markers and with the fatigue of the subject. Visual analog scale from minimum (energetic, no fatigue) to maximum (worst fatigue possible)
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
VAS-Anxiety.
The score to the VAS-Anxiety. This measure links the vocal markers and the anxiety level of the subject. Visual analog scale from minimum (calm) to maximum (anxious)
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
PVT
The score to the PVT . This links the vocal markers of the subject to its level of performance.
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
lexical decision
The scores to the lexical decision task
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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