The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

NCT ID: NCT04193891

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2020-05-26

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diet Group

Participants choosing to newly initiate the modified Atkins diet, a high fat low carb diet, for improved epilepsy control.

Modified Atkins Diet

Intervention Type: OTHER

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.

Control Group

Participants not choosing to initiate dietary therapy for epilepsy. The participants in the control group will continue with the treatment regimen they have chosen together with their physician.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of epilepsy

• Diet arm - participants who plan to newly initiate treatment with the Modified Atkins Diet (MAD) within the next 2 months as an adjunctive treatment for epilepsy
• Control arm - participants who do not plan to initiate ketogenic dietary therapy in the next 6 months

Exclusion Criteria

• Diagnosed sleep disorders (obstructive sleep apnea, primary insomnia, idiopathic hypersomnia, narcolepsy type I or II, REM sleep behavior disorder)
• Previously attempted dietary therapy for epilepsy who were not successful or compliant
• Anticipated need to adjust anti-seizure medications within the next 3 months
• Already on a ketogenic diet at the beginning of the study
• Planning to pursue surgical treatment for epilepsy in the next 6 months
• Non-English speakers
• At the discretion of the PI
• Live greater than 20 miles from the greater Madison area (in case there is a need to personally pick up the home sleep monitor at the participant's home)
• More than two no show appointments in the past 6 months

• Unwilling to restrict carbohydrates
• Significantly underweight (BMI <18.5)
• Kidney disease
• Metabolic or mitochondrial disorder
• Pregnancy
• Aversion to liquids or inability to eat solid food
• At the discretion of the PI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wisconsin Institute for Clinical and Translational Research

UNKNOWN

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Felton, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

Felton EA, Cervenka MC. Dietary therapy is the best option for refractory nonsurgical epilepsy. Epilepsia. 2015 Sep;56(9):1325-9. doi: 10.1111/epi.13075. Epub 2015 Jul 22.

Reference Type: BACKGROUND

PMID: 26198999 (View on PubMed)

Other Identifiers

A535100

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/NEUROLOGY/NEUROLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

5UL1TR002373-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 3/8/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1033

Identifier Type: -

Identifier Source: org_study_id