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

Обзор

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.

Вмешательства

• Поведенческое Monitoring of eating behaviors
  Overall eating behaviors will be assessed from pictures of consumed food and drinks taken by the participants with their smartphones. A complete assessment of eating habits will be carried out daily for 4 days. For each photo, the participants will indicate the reasons why they ate by completing analogical scales (hunger, craving, sleepiness, stress, negative emotion) and an open question (other reason). These data will be used to determine the reason and timing of food intake and the number of
• Поведенческое Monitoring of sleep/wake rhythm
  The sleep-wake rhythm will be measured continuously during the 5 days, both subjectively (sleep diary) and objectively, using the GT9X "LINK" ACTIGRAPH.
• Поведенческое Measure of nocturnal sleep parameters
  The quality and quantity of the participants' sleep will be recorded using the SOMFIT® device. This non-invasive portable device will allow the determination of sleep architecture as well as sleep EEG microstructure.
• Поведенческое Measure of sleepiness
  Sleepiness will be assessed by the Karolinska Sleepiness Scale (KSS) at the initiation of food intake and 30 min and 2 hours afterwards, and by analysis of EEG activity recorded by the SOMFIT® over a time window surrounding food intake. Indeed, participants will also be asked to wear the device as much as possible during the day when they are at home in order to explore sleepiness markers during wakefulness.

Первичные конечные точки

• impact of glycaemic load on sleepiness 2 hours after lunch [Срок оценки: 2 hours after lunch, from day 1 to day 3]

Вторичные конечные точки (12)

• impact of glycaemic load on sleepiness 2 hours after the start of each food intake [Срок оценки: 2 hours after the start of each food intake, from day 1 to day 3]
• impact of glycaemic load on sleepiness 30 min after the start of lunch and each food intake [Срок оценки: 30 min after the start of lunch and each food intake, from day 1 to day 3]
• impact of food intake on sleepiness 30 minutes and 2 hours after the start of lunch and each food intake [Срок оценки: 30 minutes and 2 hours after the start of lunch and each food intake, from day 1 to day 3]
• impact of glycaemic load and food intake on sleepiness 30 minutes and 2 hours after the start of lunch and each food intake [Срок оценки: 30 minutes and 2 hours after the start of of lunch and each food intake, from day 1 to day 3]
• Impact of glycaemic load and food intake on EEG markers of sleepiness 30 minutes and 2 hours after the start of lunch and each food intake [Срок оценки: 30 minutes and 2 hours after the start of lunch and each food intake, from day 1 to day 3]
• Impact of subjective and objective markers of sleepiness on food intake [Срок оценки: During all food intakes, from day 1 to day 3]
• relationship between the temporal course of interstitial glucose and that of objective markers of sleepiness [Срок оценки: from 1 hour before to 2 hours after each food intake, from day 1 to day 3]
• To compare the distribution (time, night versus day) of food intake between the 3 groups. [Срок оценки: From day 1 to day 3]
• To compare the motivation for eating between the 3 groups. [Срок оценки: From day 1 to day 3]
• To compare the quantity of food intake between the 3 groups. [Срок оценки: From day 1 to day 3]
• To compare the quality of food intake between the 3 groups. [Срок оценки: From day 1 to day 3]
• links between the characteristics of food intake and indicators of overweight/obesity, sleepiness and sleep quality [Срок оценки: At baseline and from day 1 to day 3]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 2 центра

• Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand — Clermont-Ferrand
• Center for Sleep Medicine, Hospices Civils de Lyon — Lyon

Идентификаторы

NCT: NCT06484348 · 69HCL22_0943

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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