Clinical trial NCT06484348: Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Official title: Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Narcolepsy Type 1
Idiopathic Hypersomnia
Keywords: Narcolepsy type 1
Idiopathic Hypersomnia
Obesity
Food intake
Disrupted nighttime sleep
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 20 NT1 patients, 20 IH patients and 20 Healthy Controls (HC) matched for age and gender will be prospectively included. The NT1 patients and HC groups will also matched for and be split into 2 subgroups of 10 participants according to BMI (\<25 kg/m2 and ≥ 25 kg/m2). IH will be matched to NT1 for wake-promoting drugs dosage.
Primary purpose: BASIC_SCIENCE

Brief summary: 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. 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.


Eligibility 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

Primary outcomes:
measure: impact of glycaemic load on sleepiness 2 hours after lunch
timeFrame: 2 hours after lunch, from day 1 to day 3
Secondary outcomes:
measure: impact of glycaemic load on sleepiness 2 hours after the start of each food intake
timeFrame: 2 hours after the start of each food intake, from day 1 to day 3
measure: impact of glycaemic load on sleepiness 30 min after the start of lunch and each food intake
timeFrame: 30 min after the start of lunch and each food intake, from day 1 to day 3
measure: impact of food intake on sleepiness 30 minutes and 2 hours after the start of lunch and each food intake
timeFrame: 30 minutes and 2 hours after the start of lunch and each food intake, from day 1 to day 3
measure: impact of glycaemic load and food intake on sleepiness 30 minutes and 2 hours after the start of lunch and each food intake
timeFrame: 30 minutes and 2 hours after the start of of lunch and each food intake, from day 1 to day 3
measure: 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
timeFrame: 30 minutes and 2 hours after the start of lunch and each food intake, from day 1 to day 3
measure: Impact of subjective and objective markers of sleepiness on food intake
timeFrame: During all food intakes, from day 1 to day 3
measure: relationship between the temporal course of interstitial glucose and that of objective markers of sleepiness
timeFrame: from 1 hour before to 2 hours after each food intake, from day 1 to day 3
measure: To compare the distribution (time, night versus day) of food intake between the 3 groups.
timeFrame: From day 1 to day 3
measure: To compare the motivation for eating between the 3 groups.
timeFrame: From day 1 to day 3
measure: To compare the quantity of food intake between the 3 groups.
timeFrame: From day 1 to day 3
measure: To compare the quality of food intake between the 3 groups.
timeFrame: From day 1 to day 3
measure: links between the characteristics of food intake and indicators of overweight/obesity, sleepiness and sleep quality
timeFrame: At baseline and from day 1 to day 3
measure: Identify the factors associated with the presence of eating disorders
timeFrame: At baseline
measure: Identification of factors associated with the presence of binge eating behaviors
timeFrame: At baseline and from day 1 to day 3
measure: Identification of factors associated with the presence of night eating syndrome
timeFrame: At baseline and from day 1 to day 3
measure: Identification of factors associated with the characteristics of eating behaviors
timeFrame: At baseline and from day 1 to day 3
measure: response of interstitial glycaemia levels following a calibrated glucose load test and the impact of this response on subjective and objective markers of sleepiness
timeFrame: from t0 to t120 minutes after a calibrated glucose load, at the end of the study (between day 4 and day 7)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand
city: Lyon
country: France
facility: Center for Sleep Medicine, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Laure PETER-DEREX, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: