Sleep DeprivationSOMVOICENCT04942574
Voice Biomarkers to Predict Excessive Daytime Sleepiness
A study testing Total sleep deprivation and Normal sleep in people with Sleep Deprivation, run by University Hospital, Bordeaux at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Total sleep deprivation and Normal sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep Deprivation
- Being tested
- Total sleep deprivation, Normal sleep
- Keywords
- Sleep Deprivation, Voice biomarkers, sleepiness
- Medical subject headings
- Sleep Deprivation, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total sleep deprivationOther
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 sleepOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Total sleep deprivation; Other: Normal sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Secondary outcomes (6)
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.
Measured: 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
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)
Measured: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
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)
Measured: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
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)
Measured: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
PVT
The score to the PVT . This links the vocal markers of the subject to its level of performance.
Measured: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
lexical decision
The scores to the lexical decision task
Measured: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start7 Feb 2022
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a monocentric exploratory study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942574
- Sponsor's protocol ID
- CHUBX 2020/57
- Acronym
- SOMVOICE
- Status last verified
- Sep 2024
- First submitted
- 18 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Biomarkers to Predict Excessive Daytime Sleepiness
- ClinicalTrials.gov ID
- NCT04942574
- Acronym / sponsor ID
- SOMVOICE / CHUBX 2020/57
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Deprivation, Voice biomarkers, sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a monocentric exploratory study.
| Arm | Type | Receives |
|---|---|---|
| First experimental visit : Total Sleep Deprivation | Experimental | Other: Total sleep deprivation, Other: Normal sleepThe 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. |
| First experimental visit : Normal Sleep | Experimental | Other: Total sleep deprivation, Other: Normal sleepThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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),
Key exclusion criteria (20 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total sleep deprivationParticipants 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. | Other | First experimental visit : Normal Sleep, First experimental visit : Total Sleep Deprivation |
| Normal sleepParticipants 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. | Other | First experimental visit : Normal Sleep, First experimental visit : Total Sleep Deprivation |
Primary outcome
Acoustic fingerprint
Time frame: Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Acoustic fingerprint (statistics on prosody, frequency and energy) influenced by sleep deprivation measured at each iteration of TILE at visits V2 and V3.
6 secondary outcomes
sleep onset
Time frame: 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
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
VAS-Fatigue
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
VAS-Anxiety.
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
PVT
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
lexical decision
Time frame: Visit (V2) between 7 and 10 days after inclusion (V1) and Visit 3 (V3) between 14 and 60 days after inclusion (V1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total sleep deprivation and Normal sleep in people with Sleep Deprivation, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic fingerprint (time frame: Visit 3 (V3) between 14 and 60 days after inclusion (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.