Voice Biomarkers to Predict Excessive Daytime Sleepiness

NCT04942574 | Completed

• 1 other identifier: CHUBX 2020/57
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Keywords

Sleep Deprivation; Voice biomarkers; sleepiness

Outcome Measures

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.

  Visit 3 (V3) between 14 and 60 days after inclusion (V1)

Secondary Outcomes (6)

• sleep onset

  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

  Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)

• VAS-Fatigue

  Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)

• VAS-Anxiety.

  Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)

• PVT

  Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)

Study Arms (2)

First experimental visit : Total Sleep Deprivation

EXPERIMENTAL

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

First experimental visit : Normal Sleep

EXPERIMENTAL

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

Total sleep deprivation OTHER

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.

First experimental visit : Normal Sleep; First experimental visit : Total Sleep Deprivation

Normal sleep OTHER

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.

First experimental visit : Normal Sleep; First experimental visit : Total Sleep Deprivation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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,

You may not qualify if:

• 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),

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Sleep Deprivation; Sleepiness

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a monocentric exploratory study.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: February 7, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)