Voice Biomarkers to Predict Excessive Daytime Sleepiness

Sleep Deprivation Clinical Trial

— SOMVOICE  

Official title:

Voice Biomarkers to Predict Excessive Daytime Sleepiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942574
• Other study ID #: CHUBX 2020/57
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: Pierre PHILIP, Pr
• Phone: 05 57 82 01 72
• Email: pierre.philip[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 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 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.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Sleep Deprivation
• Sleepiness

Intervention

Other:
• 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 total sleep deprivation.
• 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 normal sleep.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	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.	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	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)	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	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)	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	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)	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	PVT	The score to the PVT . This links the vocal markers of the subject to its level of performance.	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary	lexical decision	The scores to the lexical decision task	Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)