Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06484348

Deciphering How Food Intake Affects Sleepiness and Nighttime Sleep Quality in People With Type 1 Narcolepsy and Idiopathic Hypersomnia

Led by Hospices Civils de Lyon · Updated on 2024-11-12

60

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how food intake, sleepiness, and nighttime sleep quality interact in people with Type 1 Narcolepsy (NT1), Idiopathic Hypersomnia (IH), and healthy individuals. The study aims to better understand why obesity occurs frequently in NT1 patients and rarely in IH patients, focusing on how diet, body composition, and sleep patterns affect sleepiness and weight. The research explores whether eating high glycemic index foods increases sleepiness and how this might contribute to obesity in NT1 compared to IH and healthy controls. Participants will be monitored over several days using different devices and methods. Eating behaviors will be tracked through photos of meals taken with smartphones and a glucose sensor worn on the arm to monitor sugar intake. Sleep and wake patterns will be recorded using a sleep diary and an actigraphy device. Nighttime sleep quality and brain activity related to sleepiness will be measured with a portable sleep device called SOMFIT. Sleepiness will be assessed using a sleepiness scale at meal times and EEG markers recorded by the SOMFIT device. During the study, participants will provide data on their body mass index, body composition, and complete questionnaires about sleep quality, mood, and eating habits. The study will measure how glycemic load impacts sleepiness after lunch over three days. Researchers will analyze all these factors to understand the links between eating habits, sleepiness, and obesity. The overall study duration includes 4 to 5 days of at-home monitoring and assessments to gather comprehensive information.

CONDITIONS

Official Title

Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Type 1 Narcolepsy or Idiopathic Hypersomnia diagnosed by ICSD-3-TR or healthy controls without sleep disorder
  • Familiar use of a smartphone
Not Eligible

You will not qualify if you...

  • Untreated moderate or severe sleep apnea syndrome
  • Cognitive disorders incompatible with the study
  • Unstable treatment or treatment with sodium oxybate
  • Unstable medical or psychiatric conditions
  • Shift work
  • Pregnancy or breastfeeding
  • Diabetes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Not Yet Recruiting

2

Center for Sleep Medicine, Hospices Civils de Lyon

Lyon, France, 69004

Actively Recruiting

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Research Team

L

Laure PETER-DEREX, MD-PhD

S

Solène PANTEL

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

Frequently Asked Questions

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