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NCT06484348Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness. Obesity is observed in 30-50% of patients with Narcolepsy type 1 (NT1). Its determinism may involve transient changes in basal metabolism at the early stage of the disease, eating disorders, disrupted nighttime sleep and sleepiness. In contrast, patients suffering from idiopathic hypersomnia (IH), whose nocturnal sleep is generally long and of good quality, rarely present with obesity. By studying the relationships between diet, body composition and sleep patterns in these two populations and in healthy controls, the NARCOFOOD study aims to provide a better understanding of the determinants of obesity in narcolepsy and, more generally, of the effects of food intake on sleepiness. Patients will be recruited at the Lyon and Clermont-Ferrand sleep centers and Controls at the Lyon Neuroscience Research Center or through communications to the general public. Data from clinical evaluation (including body mass index and body composition), and questionnaires (sleep quality, insomnia, sleepiness, anxiety and depression, impulsivity, eating behaviors) will be collected. During 4 days, at home, the following parameters will be explored : 1) eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2) sleep/wake rhythm (diary and actigraphy) 3) nocturnal sleep parameters (Somfit device) 4) sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals. The hypothesis is that increased sleepiness would favor food intake of high GI foods, which would worsen sleepiness in all 3 groups, with a more pronounced effect in NT1. Compared to IH patients and controls, NT1 patients may present more snacking of high GI foods, especially at night if sleep is disrupted, and this would be correlated with body composition. The findings will help to better understand the mechanisms of obesity in narcolepsy and may lay the ground for the development of new therapeutic strategies in disorders of hypersomnolence, targeting dietary behaviors.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
76 (estimated)
First submitted
27 May 2024
Start date
16 Oct 2024
Primary completion date
16 Oct 2026
Lead sponsor
Hospices Civils de Lyon
Diseases
Obesity
NCT number
NCT06484348

What you commit to

  • Study type: Interventional
  • Planned participants: 76
  • From 16 Oct 2024 to the primary completion date, 16 Oct 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Untreated moderate or severe sleep apnea syndrome;
  • Cognitive disorders incompatible with the protocol;
  • Unstable medical or psychiatric pathology;
  • Diabetes

Lab values

  • Unstable treatment or treatment with sodium oxybate;

Other

  • Shift work;
  • Pregnancy or breastfeeding;

Who the study is looking for

  • Patients with NT1 or IH (ICSD-3-TR) or Healthy Controls without sleep disorder
  • Familiar use of a smartphone

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting
Center for Sleep Medicine, Hospices Civils de Lyon
Coordinator of this site? Confirm its status
LyonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.