Understanding how food intake affects sleep in narcolepsy and hypersomnia patients
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
This study is testing how what people eat affects their sleep and daytime sleepiness in patients with narcolepsy and hypersomnia to find better ways to manage their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT06484348 on ClinicalTrials.gov |
What this trial studies
This study investigates the complex relationships between food intake, sleepiness, and nighttime sleep quality in patients with Type 1 Narcolepsy and Idiopathic Hypersomnia. It aims to explore how dietary habits and sleep patterns influence obesity and overall health in these populations compared to healthy controls. Participants will be monitored for their eating behaviors, sleep/wake rhythms, and sleep parameters to gather comprehensive data on these interactions. The findings could lead to better management strategies for obesity in narcolepsy patients and insights into the effects of diet on sleep quality.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Type 1 Narcolepsy or Idiopathic Hypersomnia, as well as healthy controls without sleep disorders.
Not a fit: Patients with untreated moderate or severe sleep apnea, cognitive disorders, or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into dietary interventions that improve sleep quality and reduce obesity in patients with narcolepsy.
How similar studies have performed: While there is existing research on sleep and diet, this specific approach focusing on narcolepsy and hypersomnia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Patients with NT1 or IH (ICSD-3-TR) or Healthy Controls without sleep disorder * Familiar use of a smartphone Exclusion Criteria : * Untreated moderate or severe sleep apnea syndrome; * Cognitive disorders incompatible with the protocol; * Unstable treatment or treatment with sodium oxybate; * Unstable medical or psychiatric pathology; * Shift work; * Pregnancy or breastfeeding; * Diabetes
Where this trial is running
Clermont-Ferrand and 1 other locations
- Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Center for Sleep Medicine, Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Laure PETER-DEREX, MD-PhD — Hospices Civils de Lyon
- Study coordinator: Laure PETER-DEREX, MD-PhD
- Email: Laure.peter-derex@chu-lyon.fr
- Phone: +33 472071929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.