Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-27
Brief Title:
Deciphering the Interactions Between Food Intake Sleepiness and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Deciphering the Interactions Between Food Intake Sleepiness and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NARCOFOOD
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 sleepwake 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
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 sleepwake 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None