NCT04193891

The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy: a Pilot Study.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

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.

Detailed description

Twenty participants, 10 participants on the modified Atkins diet and 10 control participants, will be enrolled in the study. All participants will fill out validated sleep questionnaires and complete sleep and seizure diaries. Furthermore, all participants will wear actigraphy watches prior to ketogenic dietary therapy initiation as well as four to six weeks after being on the diet. For control participants, the actigraphy will be completed at two time points to mimic that of the participants in the dietary therapy group. For the home sleep studies for the subset of participants, these will be completed at similar time intervals as that of the actigraphy. Adherence to the diet will be monitored according to standard medical management; for any participant on the diet, he or she will keep track of food intake and track ketones, which will be submitted at the four to six week follow-up visit.

Conditions

• Epilepsy
• Seizures

Interventions

Type	Name	Description
OTHER	Modified Atkins Diet	The ketogenic diet, where individuals restrict their carbohydrate intake and significantly increase their intake of fats, was initially primarily used in children with severe epilepsy, often due to genetic syndromes. Recently, with the advent of slightly less restrictive forms of ketogenic dietary therapy (e.g. the modified Atkins diet), it has begun to be used in adults with intractable seizures who are not surgical candidates.

Timeline

• Start date: 2020-02-12
• Primary completion: 2020-05-26
• Completion: 2020-05-26
• First posted: 2019-12-10
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States