Actively Recruiting

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

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

Led by Hospices Civils de Lyon · Updated on 2026-06-03

76

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the complex links between sleep and food intake, focusing on patients with Narcolepsy type 1 (NT1), idiopathic hypersomnia (IH), and healthy individuals. The study aims to understand why obesity is common in 30-50% of NT1 patients but rare in IH patients, exploring how diet, body composition, and sleep patterns interact in these groups. This research may help reveal causes of obesity in narcolepsy and how food affects sleepiness. Participants will be monitored over several days for eating behaviors, including meal photos and sugar intake using a sensor that measures glucose levels. Sleep and wake rhythms will be tracked with diaries and actigraphy devices. Nocturnal sleep quality and quantity will be measured using a portable device that records sleep patterns and brain activity. Sleepiness will be assessed with a sleepiness scale and EEG markers before and after meals. During the study, participants will provide data on body mass index, body composition, and complete questionnaires about sleep quality, anxiety, depression, and eating behaviors. The study will measure how glycemic load affects sleepiness at various times after food intake and examine the timing, quantity, and quality of food consumed. Researchers will also explore the relationship between glucose levels and sleepiness markers. The total participation involves clinical evaluations and home monitoring over several days to better understand dietary and sleep interactions.

CONDITIONS

Brief 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 Narcolepsy type 1 or Idiopathic Hypersomnia diagnosed by ICSD-3-TR, or healthy controls without sleep disorders
  • Familiarity with using a smartphone
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Untreated moderate or severe sleep apnea syndrome
  • Cognitive disorders incompatible with the study protocol
  • 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Monitoring

Duration - 4 to 5 days

Participants will monitor their eating behaviors by taking pictures of consumed food and drinks daily for 4 days, and wear a sensor measuring glucose levels continuously. They will also keep a sleep diary and wear actigraphy and a portable sleep device to record sleep quality and sleepiness markers during this period.

Daily self-monitoring and device use over 4 to 5 days

Glucose Load Test and Assessment

Duration - Up to 4 days (between day 4 and day 7)

Participants undergo a calibrated glucose load test between day 4 and day 7, with continuous monitoring of glucose levels and assessments of subjective and objective markers of sleepiness over 2 hours following the test.

1 visit for glucose load test with 2 hours of monitoring

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

Loading map...

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

Similar Trials

A Chronobiological Treatment Combining Evening Melatonin and...

Idiopathic Hypersomnia

Actively Recruiting

1 location

A Phase 2 Long-term Extension Study of the Safety and Effica...

Narcolepsy Type 1

Actively Recruiting

24 locations

An Open-Label, Long-Term Extension Study to Investigate the ...

Narcolepsy Type 1

Actively Recruiting

46 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here