Homeostatic Regulation of Sleep in Short Sleepers

NCT07584538 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Short Sleepers
  • Normal Sleepers
  • Idiopathic Hypersomnia Patients

Interventions

PROCEDURE

Actigraphy

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.

PROCEDURE

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

TILE test

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.

PROCEDURE

PVT

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.

BIOLOGICAL

Blood sample

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.

PROCEDURE

Freestyle Libre® senso

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

BEHAVIORAL

Questionnaires

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."

PROCEDURE

Home EEG monitoring

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.

PROCEDURE

Bioelectrical impedance analysis

Will be conducted to evaluate body composition, including fat mass, lean mass, and total body water.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584538 on ClinicalTrials.gov