Homeostatic Regulation of Sleep in Short Sleepers
HOMEOSHORT
1 other identifier
interventional
75
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 20, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 13, 2026
May 1, 2026
1 year
April 20, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 17
Secondary Outcomes (19)
Changes in EEG spectral activity
Day 17
24-hour glycemic variability
Up to Day 18
Lean mass index
Up to Day 18
Fat mass index
Up to Day 18
Physical activity level assessed using the International Physical Activity Questionnaire IPAQ
Baseline visit (V1)
- +14 more secondary outcomes
Study Arms (3)
Short sleepers
ACTIVE COMPARATORAverage sleep duration \< 6 hours per night
Normal sleepers
EXPERIMENTALSleep duration between 7 and 9 hours per night
Long sleepers / Idiopathic Hypersomnia (IH)
EXPERIMENTALPresenting excessive daytime sleepiness, sleep duration \> 9 hours per night
Interventions
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.
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
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.
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.
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.
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
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."
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.
Will be conducted to evaluate body composition, including fat mass, lean mass, and total body water.
Eligibility Criteria
You may qualify if:
- 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:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gui de Chauliac - CHU Montpellier
Montpellier, 34000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2026
First Posted
May 13, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
May 13, 2026
Record last verified: 2026-05