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NCT04193891 · ClinicalTrials.gov registry record
The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy
A clinical trial, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- 2
- Enrollment target
NCT04193891: Clinical Trial study, sponsored by University of Wisconsin, Madison.
NCT04193891 is a clinical trial that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04193891 was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
The modified Atkins diet, a form of ketogenic therapy in which individuals severely restrict their carbohydrate intake and subsequently enter ketosis, has begun to be used as an adjunctive treatment in adults with intractable epilepsy who are not surgical candidates. In this study, the investigators examine the effect of ketogenic dietary therapy on sleep, as sleep deprivation is one of the most common seizure triggers and seizures themselves have been found to affect sleep quality. This pilot study will enroll twenty participants, ten of whom are initiating ketogenic dietary therapy and ten participants who are being treated with standard anti-seizure drug therapy.
Primary Outcome
The Epworth Sleepiness Scale is a survey where participants score their chance of dozing (0-3, where 0 is 'would never doze', 1 is 'slight chance of dozing', 2 is 'moderate chance of dozing', and 3 is 'high chance of dozing') in 8 different situations. The total range in scores is 0-24 where higher scores indicate higher chances of dozing.
Interventions
- OTHER Modified Atkins Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2020-05-26 |
Why NCT04193891 stopped before completion
NCT04193891 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Modified Atkins Diet is the first listed.
NCT04193891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04193891 about?
NCT04193891 is a clinical study titled "The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy". The modified Atkins diet, a form of ketogenic therapy in which individuals severely restrict their carbohydrate intake and subsequently enter ketosis, has begun to be used as an adjunctive treatment in adults with intractable epilepsy who are not surgical candidates. In this study, the investigators...
What is the current status of trial NCT04193891?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2020-02-12. Estimated completion is 2020-05-26.
What interventions are being tested in trial NCT04193891?
The interventions under investigation include: Modified Atkins Diet (OTHER).
Who is sponsoring clinical trial NCT04193891?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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