Short SleepersHOMEOSHORTNCT07584538
Homeostatic Regulation of Sleep in Short Sleepers
A study testing Actigraphy, Polysomnographie (PSG 128) and TILE test in people with Short Sleepers and Normal Sleepers, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This single-center study targets adults with distinct sleep profiles, divided into three categories: natural short sleepers, characterized by a reduced nocturnal sleep duration; subjects with idiopathic hypersomnia (IH) followed at the Sleep Disorders Unit of CHU Gui de Chauliac, with excessive daytime sleepiness; and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Short Sleepers, Normal Sleepers, Idiopathic Hypersomnia Patients
- What is being tested?
- Actigraphy, Polysomnographie (PSG 128) and TILE test
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged ≥ 18 years
- Be affiliated with a social security system
- Be able to understand the nature, purpose, and methodology of the study and agree to cooperate during clinical and polysomnographic assessments
- Be fluent in French (speaking and writing)
- Have provided written informed consent
- Sleep duration:
Show all 13Show fewer
- Short sleepers:
- Weekday sleep duration ≤ 6 hours, with no significant increase at the weekend (weekend sleep duration ≤ 7 hours) and no complaints of daytime sleepiness (ESS <10).
- -Normal sleepers: Weekday sleep duration of between 7 and 8 hours, with weekend sleep duration generally similar or slightly longer (between 7 and 9 hours), reflecting a normal sleep duration without restriction or significant catch-up sleep, and with no complaints of daytime sleepiness (ESS <10).
- -HI subjects, with increased sleep duration: Increased sleep need, with a reported sleep duration of ≥ 10 hours per night and > 11 hours over a 24-hour period; increased sleep duration associated with excessive daytime sleepiness not explained by another sleep disorder.
- No other sleep disorders
- Apnoea-hypopnoea index (AHI) ≤ 15/h
- Periodic limb movement index ≤ 15/h
Who cannot join
- Pre-existing sleep disorders
- Use of medication that affects sleep (such as sedatives, antidepressants, and insomnia medication);
- Use of substances that disrupt sleep or reduce fatigue
- Serious psychiatric disorders
- Pregnancy or breastfeeding
- Persons deprived of their liberty (by court order or administrative decision)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This single-center study targets adults with distinct sleep profiles, divided into three categories: natural short sleepers, characterized by a reduced nocturnal sleep duration; subjects with idiopathic hypersomnia (IH) followed at the Sleep Disorders Unit of CHU Gui de Chauliac, with excessive daytime sleepiness; and control normal sleepers, with standard sleep duration and no specific complaints.
The aim of this study is to analyze the mechanisms of slow-wave regulation during sleep according to sleep phenotype (normal, short, and long sleepers/idiopathic hypersomnia) by examining the decay of EEG spectral power in the delta band over central regions during the first night of continuous 32-hour recording.
Read the detailed description
Sleep is a fundamental biological process essential for maintaining brain and systemic homeostasis, playing a key role in regulating cognitive, metabolic, and emotional functions. Over the past decades, numerous studies have shown that chronic sleep deprivation is associated with an increased risk of cardiovascular disease, diabetes, metabolic disorders, and cognitive deficits.
However, individuals differ in the amount of sleep they need for optimal functioning, suggesting inter-individual variability in homeostatic sleep regulation. Slow waves during sleep (0.5-4 Hz) are central to this regulation and closely reflect sleep pressure accumulated during wakefulness. During deep sleep, slow waves support the reorganization of neural connections, brain detoxification, and restoration of energy reserves. A reduction in slow-wave power, observed with aging or in pathological conditions, has been linked to reduced recovery capacity and increased cognitive vulnerability.
Sleep need is partly determined by genetics and varies between individuals. Approximately 5-7% of the population are short sleepers, able to maintain optimal cognitive and emotional performance despite sleeping ≤6 hours per night. Previous research suggests that short sleepers may compensate for shorter sleep by increasing sleep depth in the early phases, allowing faster recovery than hypersomnia patients.
At the other end of the spectrum is idiopathic hypersomnia (IH), a condition marked by excessive sleep need and persistent daytime sleepiness despite prolonged nocturnal sleep. Its pathophysiology remains poorly understood but may involve altered slow-wave regulation and impaired homeostatic sleep pressure.
The goal of this study is to compare slow-wave architecture among short sleepers, normal sleepers, and individuals with idiopathic hypersomnia to better understand inter-individual differences in sleep homeostasis. We hypothesize that delta power decay during the first night of recording will be faster and more pronounced in short sleepers, reflecting accelerated dissipation of sleep pressure, while it will be slower and less marked in IH patients, indicating impaired homeostatic regulation. This project will provide a detailed assessment of the neurophysiological mechanisms underlying differences in sleep profiles and their implications for health and cognitive functioning.
- Being tested
- Actigraphy, Polysomnographie (PSG 128), TILE test, PVT, Blood sample
- Keywords
- Sleep architecture, Sleepiness, Polysomnography (PSG), Electroencephalogram (EEG), Delta waves, Sleep regulation, Sleep homeostasis, sleep-related quality of life
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyProcedure or surgery
Actigraphy is a non-invasive method for measuring physical activity and sleep-wake cycles over an extended period, specifically two weeks in this protocol. It uses a small, portable device, the actigraph, which is often worn on the wrist of the non-dominant arm and continuously records the participant's movements. The data collected enables the estimation of periods of sleep and wakefulness, sleep quality, and circadian rhythms.
Polysomnographie (PSG 128)Procedure or surgery
A video-polysomnography recording will be carried out to enable the scoring of the different stages of sleep and the analysis of the following parameters:
- Electroencephalogram (EEG): A high-density cap (128 electrodes) will be fitted to record brain activity
- Electromyogram (EMG): Three leads will be recorded at the chin.
- Electrooculogram (EOG): Right and left eye movements will be recorded in phase opposition
- Additional sensors will be fitted to record:
- Leg movements, using electrodes placed on the tibialis anterior muscles
- Thoracic and abdominal breathing, using respiratory plethysmography strips
- Nasal and oral airflow, via a nasal cannula,
- Oxygen saturation, using a pulse oximeter
TILE testProcedure or surgery
The modified TILE consists of five nap opportunities scheduled at 9 a.m., 11 a.m., 1 p.m., 3 p.m., and 5 p.m., during which participants are awakened after one minute of sleep to preserve the homeostatic process. Participants then undergo a modified TILE test, during which they are awakened each time they fall asleep. This allows for the measurement of sleep latency, defined as the time taken to fall asleep and the detection of abnormal REM sleep episodes.
PVTProcedure or surgery
The PVT is a standardised computer-based test lasting 5 minutes, used to assess sustained attention and psychomotor reactivity. At random intervals, a visual stimulus in the form of a digital stopwatch appears on the screen. The participant must then react as quickly as possible by pressing a button as soon as the stimulus appears, in order to stop the stopwatch. The test provides objective measures such as reaction time, the number of response omissions (lapses) and false alarms, offering a reliable indicator of alertness.
Blood sampleBiological
The first blood sample will be collected during hospitalization to obtain serum for biobank establishment, and a second blood sample will be collected at the end of the protocol to obtain serum for biobank establishment.
Freestyle Libre® sensoProcedure or surgery
The Abbott® FreeStyle Libre Pro iQ® is a continuous glucose monitoring system designed to measure interstitial glucose levels in real time in participants enrolled in clinical trials. This non-invasive, painless device is worn on the skin and continuously measures glucose concentrations in interstitial fluid, providing an accurate assessment of the glucose profile without the need for frequent blood sampling. The sensor will be fitted to provide continuous measurement of interstitial glucose levels
QuestionnairesBehavioural
During their hospital stay, participants will complete a series of questionnaires designed to document sleepiness, daytime functioning, sleep quality, dietary and physical activity habits, and circadian rhythms: ESS, KSS, FOSQ, WPAI, IHSS, ISI, IPAQ, FFQ.
Study of the chronobiological profile of participants, using the Morningness Eveningness Questionnaire (MEQ) by Horn and Östberg."
Home EEG monitoringProcedure or surgery
One week after hospitalization, sleep monitoring will be carried out at home using the Dreem® headband, a lightweight wearable EEG device designed to be worn during sleep. The headband features four electrodes positioned to measure brain activity in real time with high accuracy and connects wirelessly to a mobile application for easy data collection. It enables continuous recording of EEG signals, allowing identification of sleep stages as well as sleep microstructures such as spindles and slow waves. This recording will allow assessment of sleep quality in a natural environment and comparison of its characteristics with those observed in the laboratory.
Bioelectrical impedance analysisProcedure or surgery
Will be conducted to evaluate body composition, including fat mass, lean mass, and total body water.
| Study group | Role | What they receive |
|---|---|---|
| Short sleepers | Active comparator | Average sleep duration < 6 hours per night Receives: Procedure: Actigraphy; Procedure: Polysomnographie (PSG 128); Procedure: TILE test; Procedure: PVT; Biological: Blood sample; Procedure: Freestyle Libre® senso; Behavioral: Questionnaires; Procedure: Home EEG monitoring; Procedure: Bioelectrical impedance analysis |
| Normal sleepers | Experimental | Sleep duration between 7 and 9 hours per night Receives: Procedure: Actigraphy; Procedure: Polysomnographie (PSG 128); Procedure: TILE test; Procedure: PVT; Biological: Blood sample; Procedure: Freestyle Libre® senso; Behavioral: Questionnaires; Procedure: Home EEG monitoring; Procedure: Bioelectrical impedance analysis |
| Long sleepers / Idiopathic Hypersomnia (IH) | Experimental | Presenting excessive daytime sleepiness, sleep duration > 9 hours per night Receives: Procedure: Actigraphy; Procedure: Polysomnographie (PSG 128); Procedure: TILE test; Procedure: PVT; Biological: Blood sample; Procedure: Freestyle Libre® senso; Behavioral: Questionnaires; Procedure: Home EEG monitoring; Procedure: Bioelectrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease in EEG spectral power in the delta band (0.5-4 Hz) over the central region during the first night of a continuous 32-hour recording.
The decay dynamics will be modeled using an exponential function.
Measured: Day 17
Secondary outcomes (19)
Changes in EEG spectral activity
Variation in EEG spectral power within the 0.5-9 Hz frequency range assessed across all channels of a 128-channel EEG system during the 30 minutes following awakening
Measured: Day 17
24-hour glycemic variability
will be assessed using continuous interstitial glucose monitoring with the FreeStyle Libre® system. Glucose values, expressed in mmol/L (or mg/dL), will be recorded at regular intervals and used to calculate variability metrics, including standard deviation (SD) and coefficient of variation (CV, %).
Measured: Up to Day 18
Lean mass index
Lean mass index will be assessed using Bioelectrical Impedance Analysis (BIA).
Measured: Up to Day 18
Fat mass index
Fat mass index and fat mass index will be assessed using Bioelectrical Impedance Analysis (BIA).
Measured: Up to Day 18
Physical activity level assessed using the International Physical Activity Questionnaire IPAQ
IPAQ is a seven-question self-report questionnaire that assesses physical activity over the past 7 days and provides a total score expressed in MET-minutes per week and/or categorical activity levels (low, moderate, high)."
Measured: Baseline visit (V1)
Food Frequency Questionnaire score
The Food Frequency Questionnaire (FFQ) is a self-administered tool used to assess habitual dietary intake over a defined period, providing a quantitative estimate of dietary intake."
Measured: Baseline visit (V1)
Epworth Sleepiness Scale (ESS) score
ESS is a short 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24
Measured: Baseline visit (V1)
Idiopathic hypersomnia severity scale (IHSS) score
IHSS is a tool used to measure the severity of the symptoms experienced by patients with IH during the previous month. The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10-14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and 8 items on a 4-point Likert scale; the Likert scale is a point scale that is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0-50), and higher scores indicate more severe symptoms
Measured: Baseline visit (V1)
Karolinska Sleepiness Scale (KSS)
KSS is a self-reported measure of subjective sleepiness at a specific time point. Participants rate their level of sleepiness over the preceding 10 minutes on a 9-point Likert scale ranging from 1 ('extremely alert') to 9 ('very sleepy, fighting sleep'). The KSS provides a measure of situational sleepiness, with higher scores indicating greater sleepiness
Measured: Baseline visit (V1)
The number of sleep-onset REM periods (SOREMPs)
corresponds to the total count of REM sleep episodes occurring within 15 minutes of sleep onset across all nap trials of the Multiple Sleep Latency Test (MSLT). Typically ranging from 0 to 5, this measure reflects abnormal REM intrusion when elevated and is a key diagnostic marker for conditions such as Narcolepsy, particularly when two or more SOREMPs are observed alongside reduced mean sleep latency
Measured: Up to Day 18 (During hospitalization)
Sleep latency at each test (minutes)
is the time from lights-off to the onset of sleep during each nap trial of the Multiple Sleep Latency Test (MSLT), typically conducted across 4 to 5 sessions. Shorter sleep latencies indicate greater daytime sleepiness, while longer latencies reflect higher alertness. This measure is commonly used, alongside SOREMP detection, to help diagnose conditions such as Narcolepsy and excessive daytime sleepiness
Measured: Up to Day 18 (During hospitalization)
Mean sleep latency is the average time (in minutes)
it takes a participant to fall asleep across all nap trials of the Multiple Sleep Latency Test (MSLT). It is calculated by averaging the sleep latency values from each nap session (typically 4 to 5 tests). Lower mean sleep latency indicates greater daytime sleepiness, while higher values reflect better alertness. This parameter is a key diagnostic indicator, particularly for conditions such as Narcolepsy and excessive daytime sleepiness
Measured: Up to Day 18 (During hospitalization)
Presence of a sleep-onset REM periods (SOREMP)
refers to whether REM sleep occurs within 15 minutes after sleep onset during each nap trial of the Multiple Sleep Latency Test (MSLT). This measure is recorded as a binary outcome for each test (present = 1, absent = 0) and reflects abnormal REM intrusion when present. It is used alongside sleep latency to help identify sleep disorders such as Narcolepsy and excessive daytime sleepiness
Measured: Up to Day 18 (During hospitalization)
Questionnaire on Functional Outcomes of Sleep
FOSQ : a self-administered instrument consisting of 10 items evaluating the impact of sleepiness and fatigue on daily activities. Each item is rated on a 4- to 6-point Likert scale according to the frequency or degree of difficulty experienced, with higher scores indicating better functional status
Measured: Baseline visit (V1)
Work Productivity and Activity Impairment- General Health (WPAI:GH)
WPAI:GH is a well validated instrument to measure the effect of health conditions on work productivity and daily activities. The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS).
Measured: Baseline visit (V1)
Sleepiness severity scores on the Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia. Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)
Measured: Baseline visit (V1)
Morningness-Eveningness Questionnaire (MEQ) score
MEQ : a validated self-reported instrument evaluating individual chronotype. The MEQ provides a total score classifying participants along a continuum from eveningness to morningness, with higher scores indicating a stronger morning-type preference
Measured: Baseline visit (V1)
Psychomotor vigilance task (PVT)
PVT is a widely utilized as a measure of behavioral alertness, primary due to its high sensitivity to sleep deprivation and its psychometric advantages over other cognitive tests. The standard 10-min PVT measures sustained or vigilant attention by recording response times (RT) to visual (or auditory) stimuli presented at random inter-stimulus intervals
Measured: Up to Day 18 (During hospitalization)
Serum protein levels
Serum proteins will be collected for future exploratory analyses using the NULISA platform
Measured: Up to Day 18 (During hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short SleepersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584538
- Sponsor's protocol ID
- RECHMPL25_0538
- Acronym
- HOMEOSHORT
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeostatic Regulation of Sleep in Short Sleepers
- ClinicalTrials.gov ID
- NCT07584538
- Acronym / sponsor ID
- HOMEOSHORT / RECHMPL25_0538
- Keywords
- Sleep architecture, Sleepiness, Polysomnography (PSG), Electroencephalogram (EEG), Delta waves, Sleep regulation, Sleep homeostasis, sleep-related quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 May 2026 (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 single-center study targets adults with distinct sleep profiles, divided into three categories: natural short sleepers, characterized by a reduced nocturnal sleep duration; subjects with idiopathic hypersomnia (IH) followed at the Sleep Disorders Unit of CHU Gui de Chauliac, with excessive daytime sleepiness; and control normal sleepers, with standard sleep duration and no specific complaints.
The aim of this study is to analyze the mechanisms of slow-wave regulation during sleep according to sleep phenotype (normal, short, and long sleepers/idiopathic hypersomnia) by examining the decay of EEG spectral power in the delta band over central regions during the first night of continuous 32-hour recording.
Detailed description
Sleep is a fundamental biological process essential for maintaining brain and systemic homeostasis, playing a key role in regulating cognitive, metabolic, and emotional functions. Over the past decades, numerous studies have shown that chronic sleep deprivation is associated with an increased risk of cardiovascular disease, diabetes, metabolic disorders, and cognitive deficits.
However, individuals differ in the amount of sleep they need for optimal functioning, suggesting inter-individual variability in homeostatic sleep regulation. Slow waves during sleep (0.5-4 Hz) are central to this regulation and closely reflect sleep pressure accumulated during wakefulness. During deep sleep, slow waves support the reorganization of neural connections, brain detoxification, and restoration of energy reserves. A reduction in slow-wave power, observed with aging or in pathological conditions, has been linked to reduced recovery capacity and increased cognitive vulnerability.
Sleep need is partly determined by genetics and varies between individuals. Approximately 5-7% of the population are short sleepers, able to maintain optimal cognitive and emotional performance despite sleeping ≤6 hours per night. Previous research suggests that short sleepers may compensate for shorter sleep by increasing sleep depth in the early phases, allowing faster recovery than hypersomnia patients.
At the other end of the spectrum is idiopathic hypersomnia (IH), a condition marked by excessive sleep need and persistent daytime sleepiness despite prolonged nocturnal sleep. Its pathophysiology remains poorly understood but may involve altered slow-wave regulation and impaired homeostatic sleep pressure.
The goal of this study is to compare slow-wave architecture among short sleepers, normal sleepers, and individuals with idiopathic hypersomnia to better understand inter-individual differences in sleep homeostasis. We hypothesize that delta power decay during the first night of recording will be faster and more pronounced in short sleepers, reflecting accelerated dissipation of sleep pressure, while it will be slower and less marked in IH patients, indicating impaired homeostatic regulation. This project will provide a detailed assessment of the neurophysiological mechanisms underlying differences in sleep profiles and their implications for health and cognitive functioning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short sleepers | Active comparator | Procedure: Actigraphy, Procedure: Polysomnographie (PSG 128), Procedure: TILE test, Procedure: PVT, Biological: Blood sample, Procedure: Freestyle Libre® senso, Behavioral: Questionnaires, Procedure: Home EEG monitoring, Procedure: Bioelectrical impedance analysisAverage sleep duration < 6 hours per night |
| Normal sleepers | Experimental | Procedure: Actigraphy, Procedure: Polysomnographie (PSG 128), Procedure: TILE test, Procedure: PVT, Biological: Blood sample, Procedure: Freestyle Libre® senso, Behavioral: Questionnaires, Procedure: Home EEG monitoring, Procedure: Bioelectrical impedance analysisSleep duration between 7 and 9 hours per night |
| Long sleepers / Idiopathic Hypersomnia (IH) | Experimental | Procedure: Actigraphy, Procedure: Polysomnographie (PSG 128), Procedure: TILE test, Procedure: PVT, Biological: Blood sample, Procedure: Freestyle Libre® senso, Behavioral: Questionnaires, Procedure: Home EEG monitoring, Procedure: Bioelectrical impedance analysisPresenting excessive daytime sleepiness, sleep duration > 9 hours per night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be aged ≥ 18 years
- Be affiliated with a social security system
- Be able to understand the nature, purpose, and methodology of the study and agree to cooperate during clinical and polysomnographic assessments
- Be fluent in French (speaking and writing)
- Have provided written informed consent
Key exclusion criteria (6 listed)
- Pre-existing sleep disorders
- Use of medication that affects sleep (such as sedatives, antidepressants, and insomnia medication);
- Use of substances that disrupt sleep or reduce fatigue
- Serious psychiatric disorders
- Pregnancy or breastfeeding
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 |
|---|---|---|
| ActigraphyActigraphy is a non-invasive method for measuring physical activity and sleep-wake cycles over an extended period, specifically two weeks in this protocol. It uses a small, portable device, the actigraph, which is often worn on the wrist of the non-dominant arm and continuously records the participant's movements. The data collected enables the estimation of periods of sleep and wakefulness, sleep quality, and circadian rhythms. | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| Polysomnographie (PSG 128)A video-polysomnography recording will be carried out to enable the scoring of the different stages of sleep and the analysis of the following parameters: - Electroencephalogram (EEG): A high-density cap (128 electrodes) will be fitted to record brain activity - Electromyogram (EMG): Three leads will be recorded at the chin. - Electrooculogram (EOG): Right and left eye movements will be recorded in phase opposition - Additional sensors will be fitted to record: * Leg movements, using electrodes placed on the tibialis anterior muscles * Thoracic and abdominal breathing, using respiratory plethysmography strips * Nasal and oral airflow, via a nasal cannula, * Oxygen saturation, using a pulse oximeter | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| TILE testThe modified TILE consists of five nap opportunities scheduled at 9 a.m., 11 a.m., 1 p.m., 3 p.m., and 5 p.m., during which participants are awakened after one minute of sleep to preserve the homeostatic process. Participants then undergo a modified TILE test, during which they are awakened each time they fall asleep. This allows for the measurement of sleep latency, defined as the time taken to fall asleep and the detection of abnormal REM sleep episodes. | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| PVTThe PVT is a standardised computer-based test lasting 5 minutes, used to assess sustained attention and psychomotor reactivity. At random intervals, a visual stimulus in the form of a digital stopwatch appears on the screen. The participant must then react as quickly as possible by pressing a button as soon as the stimulus appears, in order to stop the stopwatch. The test provides objective measures such as reaction time, the number of response omissions (lapses) and false alarms, offering a reliable indicator of alertness. | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| Blood sampleThe first blood sample will be collected during hospitalization to obtain serum for biobank establishment, and a second blood sample will be collected at the end of the protocol to obtain serum for biobank establishment. | Biological | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| Freestyle Libre® sensoThe Abbott® FreeStyle Libre Pro iQ® is a continuous glucose monitoring system designed to measure interstitial glucose levels in real time in participants enrolled in clinical trials. This non-invasive, painless device is worn on the skin and continuously measures glucose concentrations in interstitial fluid, providing an accurate assessment of the glucose profile without the need for frequent blood sampling. The sensor will be fitted to provide continuous measurement of interstitial glucose levels | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| QuestionnairesDuring their hospital stay, participants will complete a series of questionnaires designed to document sleepiness, daytime functioning, sleep quality, dietary and physical activity habits, and circadian rhythms: ESS, KSS, FOSQ, WPAI, IHSS, ISI, IPAQ, FFQ. Study of the chronobiological profile of participants, using the Morningness Eveningness Questionnaire (MEQ) by Horn and Östberg." | Behavioural | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| Home EEG monitoringOne week after hospitalization, sleep monitoring will be carried out at home using the Dreem® headband, a lightweight wearable EEG device designed to be worn during sleep. The headband features four electrodes positioned to measure brain activity in real time with high accuracy and connects wirelessly to a mobile application for easy data collection. It enables continuous recording of EEG signals, allowing identification of sleep stages as well as sleep microstructures such as spindles and slow waves. This recording will allow assessment of sleep quality in a natural environment and comparison of its characteristics with those observed in the laboratory. | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
| Bioelectrical impedance analysisWill be conducted to evaluate body composition, including fat mass, lean mass, and total body water. | Procedure or surgery | Long sleepers / Idiopathic Hypersomnia (IH), Normal sleepers, Short sleepers |
Primary outcome
The decrease in EEG spectral power in the delta band (0.5-4 Hz) over the central region during the first night of a continuous 32-hour recording.
Time frame: Day 17
The decay dynamics will be modeled using an exponential function.
19 secondary outcomes
Changes in EEG spectral activity
Time frame: Day 17
24-hour glycemic variability
Time frame: Up to Day 18
Lean mass index
Time frame: Up to Day 18
Fat mass index
Time frame: Up to Day 18
Physical activity level assessed using the International Physical Activity Questionnaire IPAQ
Time frame: Baseline visit (V1)
Food Frequency Questionnaire score
Time frame: Baseline visit (V1)
Epworth Sleepiness Scale (ESS) score
Time frame: Baseline visit (V1)
Idiopathic hypersomnia severity scale (IHSS) score
Time frame: Baseline visit (V1)
Karolinska Sleepiness Scale (KSS)
Time frame: Baseline visit (V1)
The number of sleep-onset REM periods (SOREMPs)
Time frame: Up to Day 18 (During hospitalization)
Sleep latency at each test (minutes)
Time frame: Up to Day 18 (During hospitalization)
Mean sleep latency is the average time (in minutes)
Time frame: Up to Day 18 (During hospitalization)
Presence of a sleep-onset REM periods (SOREMP)
Time frame: Up to Day 18 (During hospitalization)
Questionnaire on Functional Outcomes of Sleep
Time frame: Baseline visit (V1)
Work Productivity and Activity Impairment- General Health (WPAI:GH)
Time frame: Baseline visit (V1)
Sleepiness severity scores on the Insomnia Severity Index (ISI)
Time frame: Baseline visit (V1)
Morningness-Eveningness Questionnaire (MEQ) score
Time frame: Baseline visit (V1)
Psychomotor vigilance task (PVT)
Time frame: Up to Day 18 (During hospitalization)
Serum protein levels
Time frame: Up to Day 18 (During hospitalization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy, Polysomnographie (PSG 128) and TILE test in people with Short Sleepers and Normal Sleepers, run by University Hospital, Montpellier 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 13 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves DAUVILLIERS, Pr (04.67.33.63.61, y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease in EEG spectral power in the delta band (0.5-4 Hz) over the central region during the first night of a continuous 32-hour recording. (time frame: Day 17). 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 13 May 2026.