ClinicalTrials.gg
CompletedNCT04942574SOMVOICEUpdated Sep 19, 2024

Voice Biomarkers to Predict Excessive Daytime Sleepiness

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Sleep Deprivation

Keywords

  • Sleep Deprivation
  • Voice biomarkers
  • sleepiness
03

In context

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 →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Male ou female volunteers, who are between 18 and 50 years old,
  • With a (Body Mass Index) between 18.5 and 25 kg/m2 for volunteers who are between 18 and 34 years old, or a BMI between 18.5 and 27 kg/m2 for volunteers who are between 35 and 50 years old ,
  • Not having subjective EDS (Excessive Daytime Sleepiness) : total score at ESS (Epworth Sleepiness Scale) lower or equal to 11,
  • Not having insomnia complaints (ISI total score lower than 8),
  • Having a SCL90R (Symptom Check List- 90 items Revised) score lower than 60 (only for Anxiety and Depression categories' items of the checklist),
  • Regular bedtime between 22H00 and 0H00, regular get up time between 6H00 and 8H00,
  • Daily TST (Total Sleep Time) between 7 and 9 hours,
  • With no strong suspicion of OSAS (Obstructive Sleep Apnea Syndrome) as assessed by STOP-BANG questionnaire,
  • With no suspicion of RLS (Restless Legs Syndrome) as assessed by RLS screening questionnaire,
  • With sufficient reading abilities for the reading task as assessed by ECLA16+ ("Evaluation des Compétences de Lecture chez l'Adulte de plus de 16 ans" :

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),

  • With a SE (Sleep Efficiency) higher or equal to 85% as assessed by the 7 nights-actigraphy made before inclusion,
  • With an AHI (Apnea/Hypopnea Index) lower or equal to 10 apnea or hypopnea/hour of sleep as assessed by the ventilatory polygraphy,
  • With a PLMI (Periodic Limb Movement Index) lower or equal to 15 sequences of PLM/hour of sleep as assessed by the ventilatory polygraphy,
  • Being an affiliated member of the Social Security system,
  • Being able to understand the study,
  • Being available to come at the four visits necessary for the study,
  • Having given written to participate to the study.

Exclusion criteria

Exclusion Criteria:

  • Having a life-threatening disease,
  • Any evolutive cardiovascular pathology - under treatment or not,
  • Any evolutive neurologic pathology - under treatment or not (brain tumour, epilepsy, headache, stroke, sclerosis, myoclonia, chorea, neuropathy, muscular dystrophies, myotonic dystrophy),
  • Psychiatric disorders - under treatment or not (characterised depressive episode, bipolar disorders, psychotic disorders, neurodevelopmental diseases),
  • Untreated endocrine disorders (diabetes, hyperthyroidism),
  • Dependency to a substance,
  • otorhinolaryngological disorder that could induce vocal parameters modification,
  • Fluence disorders (cluttering, stuttering), language disorders (dyslexia) or visual troubles that could impact reading abilities,
  • Participant under psychotropic treatment (antidepressants, antihistamine, etc...), or under treatment that could interfere with sleep or wakefulness level,
  • Participant under treatment that could impact the normal muscular function (myorelaxant, neuromuscular blocking agents injections in maxillofacial area, etc...),
  • Dental care during the follow-up of the study,
  • Shift-worker or night-worker,
  • Excessive consumption of alcohol (>2 glasses per day) during the 6 last months,
  • Excessive consumption of coffee, tea, or any drink containing caffeine (like cola) (> 5 cups/day),
  • Excessive tobacco smoking (>5 cigarets/day),
  • Non-native French speaker,
  • Participant with a thick accent that could induce significantly vocal parameters modification (at the discretion of the investigator),
  • Deprived of liberty by a legal or administrative procedure,
  • Under tutorship or guardianship,
  • Pregnant or breastfeeding woman.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    First experimental visit : Total Sleep Deprivation

    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

  • Experimental
    First experimental visit : 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

Interventions

  • OtherTotal 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 total sleep deprivation.

  • OtherNormal 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 normal sleep.

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

07

Study locations

1 site
  • CHU de Bordeaux
    Bordeaux, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04942574
Responsible party
Sponsor
First posted
Jun 28, 2021
Start date
Feb 7, 2022
Primary completion
Jun 10, 2024
Completion
Jun 10, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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