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Voice Biomarkers to Predict Excessive Daytime Sleepiness (SOMVOICE)

Primary Purpose

Sleep Deprivation

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Total sleep deprivation

Normal sleep

About this trial

This is an interventional basic science trial for Sleep Deprivation focused on measuring Sleep Deprivation, Voice biomarkers, sleepiness

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male ou female volunteers, who are between 18 and 50 years old,
With a BMI (Body Mass Index) between 18.5 and 25 kg/m2,
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 informed consent to participate to the study.

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.

Sites / Locations

CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

First experimental visit : Total Sleep Deprivation

First experimental visit : Normal Sleep

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

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)

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)

PVT

The score to the PVT . This links the vocal markers of the subject to its level of performance.

lexical decision

The scores to the lexical decision task

Full Information

NCT ID

NCT04942574

First Posted

June 18, 2021

Last Updated

July 3, 2023

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT04942574

Brief Title

Voice Biomarkers to Predict Excessive Daytime Sleepiness

Acronym

SOMVOICE

Official Title

Voice Biomarkers to Predict Excessive Daytime Sleepiness

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2022 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation

Keywords

Sleep Deprivation, Voice biomarkers, sleepiness

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This is a monocentric exploratory study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

First experimental visit : Total Sleep Deprivation

Arm Type

Experimental

Arm Description

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.

Arm Title

First experimental visit : Normal Sleep

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Total sleep deprivation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Normal sleep

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acoustic fingerprint

Description

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 Outcome Measure Information:

Title

sleep onset

Description

Time Frame