Clinical Research Directory

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.