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临床试验/NCT06484348
NCT06484348招募中不适用

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

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
4
主要终点
impact of glycaemic load on sleepiness 2 hours after lunch

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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;

研究组 & 干预措施

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

干预措施: Monitoring of eating behaviors (Behavioral)

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

干预措施: Monitoring of sleep/wake rhythm (Behavioral)

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

干预措施: Measure of nocturnal sleep parameters (Behavioral)

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

干预措施: Measure of sleepiness (Behavioral)

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

干预措施: Monitoring of eating behaviors (Behavioral)

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

干预措施: Monitoring of sleep/wake rhythm (Behavioral)

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

干预措施: Measure of nocturnal sleep parameters (Behavioral)

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

干预措施: Measure of sleepiness (Behavioral)

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

干预措施: Monitoring of eating behaviors (Behavioral)

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

干预措施: Monitoring of sleep/wake rhythm (Behavioral)

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

干预措施: Measure of nocturnal sleep parameters (Behavioral)

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

干预措施: Measure of sleepiness (Behavioral)

结局指标

主要结局

impact of glycaemic load on sleepiness 2 hours after lunch

时间窗: 2 hours after lunch, from day 1 to day 3

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.

次要结局

  • To compare the quantity of food intake between the 3 groups.(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 subjective and objective markers of sleepiness on food intake(During all food intakes, from day 1 to day 3)
  • To compare the motivation for eating between the 3 groups.(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)
  • To compare the distribution (time, night versus day) of food intake between the 3 groups.(From day 1 to day 3)
  • relationship between the temporal course of interstitial glucose and that of objective markers of sleepiness(from 1 hour before to 2 hours after each food intake, from day 1 to day 3)
  • 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 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)
  • To compare the quality of food intake between the 3 groups.(From day 1 to day 3)
  • Identify the factors associated with the presence of eating disorders(At baseline)
  • links between the characteristics of food intake and indicators of overweight/obesity, sleepiness and sleep quality(At baseline and from day 1 to day 3)
  • Identification of factors associated with the presence of binge eating behaviors(At baseline and from day 1 to day 3)
  • Identification of factors associated with the presence of night eating syndrome(At baseline and from day 1 to day 3)
  • Identification of factors associated with the characteristics of eating behaviors(At baseline and from day 1 to day 3)
  • response of interstitial glycaemia levels following a calibrated glucose load test and the impact of this response on subjective and objective markers of sleepiness(from t0 to t120 minutes after a calibrated glucose load, at the end of the study (between day 4 and day 7))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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