G47.4
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient must have one of the following diagnoses: Narcolepsy Type 1 (according to ICSD-3) 2. Must be at least 18 years old 3. The patient must not be pregnant or breastfeeding 4. The patient must have a BMI of at least 20 kg/m² 5. The patient must have sufficient German language skills 6. Patient must have received information in accordance with the information sheet 7. Patient must have given their consent in accordance with the consent form
Exclusion criteria
Exclusion criteria: 1. Patients who are not sufficiently able to understand German, both written and spoken 2. Patients under 18 years of age 3. Patients incapable of giving consent 4. Patients with the following conditions: - severe cardiovascular diseases, such as cardiac arrhythmias, myocardial infarction, or stroke within the last 6 weeks - severe lung diseases, such as COPD 5. Patients who are following a diet at the time of study enrollment 6. Patients who participate in any form of competitive sports or are currently preparing for an intensive athletic competition 7. Patients who are taking sodium oxybate as part of their medication 8. Patients who are taking medications as part of their treatment that have a potential influence on ketogenic metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is daytime sleepiness, which is measured using the Epworth Sleepiness Scale (ESS) before the intervention, after 5 weeks of the intervention, and at the end of the 10 weeks of the intervention. The data is collected via LimeSurvey in the form of an online survey. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality, fatigue, quality of life, well-being | — |
Countries
Germany
Contacts
Universität Witten/Herdecke