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

NCT06484348 | Recruiting

• 1 other identifier: 69HCL22_0943
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Narcolepsy Type 1; Idiopathic Hypersomnia

Keywords

Narcolepsy type 1; Idiopathic Hypersomnia; Obesity; Food intake; Disrupted nighttime sleep

Outcome Measures

Primary Outcomes (1)

• impact of glycaemic load on sleepiness 2 hours after lunch

  To compare the impact of glycaemic load on sleepiness assessed by the Karolinska sleepiness scale (KSS) 2 hours after lunch (midday meal or food intake between 11 a.m. and 4 p.m.) between the 3 groups of participants (NT1, IH, CT). Correlation coefficient between the quantitative measure of glycaemic load assessed by the area under the interstitial glucose curve for 2 hours after the start of lunch and the change in sleepiness assessed by the variation in the score on the KSS between the pre- and post-prandial period, with post-prandial assessment 2 hours after the start of lunch.

  2 hours after lunch, from day 1 to day 3

Secondary Outcomes (17)

• impact of glycaemic load on sleepiness 2 hours after the start of each food intake

  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

  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

  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

  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

  30 minutes and 2 hours after the start of lunch and each food intake, from day 1 to day 3

Study Arms (3)

NT1

EXPERIMENTAL

Patients with Narcolepsy type 1 will be included in this arm. They will have following interventions : 1. monitoring of eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2. monitoring of sleep/wake rhythm (diary and actigraphy) 3. monitoring of nocturnal sleep parameters (Somfit device) 4. monitoring of sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals

Behavioral: Monitoring of eating behaviors; Behavioral: Monitoring of sleep/wake rhythm; Behavioral: Measure of nocturnal sleep parameters; Behavioral: Measure of sleepiness

IH

ACTIVE COMPARATOR

Patients with Idiopathic Hypersomnia will be included in this arm. They will have following interventions : 1. monitoring of eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2. monitoring of sleep/wake rhythm (diary and actigraphy) 3. monitoring of nocturnal sleep parameters (Somfit device) 4. monitoring of sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals

Behavioral: Monitoring of eating behaviors; Behavioral: Monitoring of sleep/wake rhythm; Behavioral: Measure of nocturnal sleep parameters; Behavioral: Measure of sleepiness

HC

ACTIVE COMPARATOR

Healthy Controls will be included in this arm. They will have following interventions : 1. monitoring of eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2. monitoring of sleep/wake rhythm (diary and actigraphy) 3. monitoring of nocturnal sleep parameters (Somfit device) 4. monitoring of sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals

Behavioral: Monitoring of eating behaviors; Behavioral: Monitoring of sleep/wake rhythm; Behavioral: Measure of nocturnal sleep parameters; Behavioral: Measure of sleepiness

Interventions

Monitoring of eating behaviors BEHAVIORAL

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 calories ingested for each food category. Eating behaviors specifically related to sugar intake will be monitored using the FREESTYLE PRO® sensor. This small device is used routinely for diabetes care and is placed on the back of the arm. The system is designed to measure glucose levels in the interstitial fluid every 15 minutes for up to 14 days. The recorded data can be downloaded by an investigator using the FREESTYLE LIBRE PRO® reader.

HC; IH; NT1

Monitoring of sleep/wake rhythm BEHAVIORAL

The sleep-wake rhythm will be measured continuously during the 5 days, both subjectively (sleep diary) and objectively, using the GT9X "LINK" ACTIGRAPH.

HC; IH; NT1

Measure of nocturnal sleep parameters BEHAVIORAL

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.

HC; IH; NT1

Measure of sleepiness BEHAVIORAL

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.

HC; IH; NT1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Unité de Neurophysiologie-sommeil, Département de Neurologie, CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Center for Sleep Medicine, Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia; Obesity

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laure PETER-DEREX, MD-PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure PETER-DEREX, MD-PhD

CONTACT

+33 472071929; Laure.peter-derex@chu-lyon.fr

Solène PANTEL

CONTACT

04 26 73 27 25; Solene.pantel02@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: July 3, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)