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The impact of ketogenic diet and physical exercise on narcolepsy type 2 and idiopathic hypersomnia: a randomized, controlled trial

The impact of ketogenic diet and physical exercise on narcolepsy type 2 and idiopathic hypersomnia: a randomized, controlled trial - Keto-Sport_NT2/IH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040939
Enrollment
60
Registered
2026-07-15
Start date
2023-09-11
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

83465 33208

Interventions

Group 1: Participants complete a training program consisting of moderate endurance training for a total of 10 weeks. Group 2: Participants follow a ketogenic diet for a total of 10 weeks. Group 3: Par

Sponsors

Universität Witten/Herdecke
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient must have one of the following diagnoses: Narcolepsy Type 2 or idiopathic Hypersomnia (according to ICSD-3-TR) 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

MeasureTime 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

MeasureTime frame
Sleep quality, fatigue, quality of life, well-being, recovery, weight-loss

Countries

Germany

Contacts

Public ContactHanna Cintosun

Universität Witten/Herdecke

Hanna.cintosun@uni-wh.de0172 / 29 30 355

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026