Effectiveness of ketogenic diet on excessive daytime sleepiness in adults with narcolepsy type 1: a proof of concept study
Recruiting
- Conditions
- low-carbohydrate high-fat10040998
- 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
Name Time Method <p>Primary endpoint of the study is sleep latency on the Maintenance of<br /><br>Wakefulness Test (MWT).</p><br>
- Secondary Outcome Measures
Name Time Method <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>