Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04942574
Other study ID # CHUBX 2020/57
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Withdrawn NCT04049682 - Start Times and Restful Sleep
Completed NCT03182413 - Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation Phase 1
Not yet recruiting NCT01930279 - Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood N/A
Completed NCT01989741 - Effect of Sleep Restriction on Decision Making and Inflammation N/A
Completed NCT00228215 - Tips for Infant and Parent Sleep (TIPS) N/A
Completed NCT00123214 - A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation N/A
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT04179838 - Olfactory Contributions to Sleep-dependent Food Craving N/A
Not yet recruiting NCT05513339 - Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
Recruiting NCT05026541 - Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT06017882 - Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Completed NCT00179322 - Effects of Sleep Deprivation and Recovery on Cognitive Functions
Recruiting NCT06399939 - The Function of Biphasic Sleep in Infants N/A
Not yet recruiting NCT06027047 - Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Completed NCT05162105 - Quick Returns - Sleep, Cognitive Functions and Individual Differences N/A
Completed NCT03981770 - Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery