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Effectiveness of ketogenic diet on excessive daytime sleepiness in adults with narcolepsy type 1: a proof of concept study

Recruiting
Conditions
low-carbohydrate high-fat
10040998
Registration Number
NL-OMON51890
Lead Sponsor
Stichting Epilepsie Instellingen Nederland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

Diagnosis of narcolepsy type 1 as classified by the International
Classification of Sleep Disorders-3 (ICSD-3)
18 years or older
Motivated to commit to the diet

Exclusion Criteria

Underweight (BMI < 18.5)
Diabetes Mellitus
Thyroid disfunction
mental / psychiatric difficulties
use of y-hydroxybutyrate
pregnant or lactating women or women trying to conceive
excessive drug or alcohol use

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoint of the study is sleep latency on the Maintenance of<br /><br>Wakefulness Test (MWT).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary parameters are sustained attention using the Sustained Attention to<br /><br>Response Task (SART), the self-reported EDS. mental wellbeing, sleep quality,<br /><br>ADHD symptoms, cataplexy, and feasibility of the ketogenic diet.</p><br>
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