The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

University of Wisconsin (UW)

Status: Terminated

Conditions: Seizures; Epilepsy

Treatments: Other: Modified Atkins Diet

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04193891

SMPH/NEUROLOGY/NEUROLOGY (Other Identifier)

A535100 (Other Identifier)

Protocol Version 3/8/2020 (Other Identifier)

2019-1033

5UL1TR002373-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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
• Standard modified Atkins diet exclusion criteria (see below)
• 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

For reference, the clinical exclusion criteria for the modified Atkins diet are listed here. These will have been verified clinically in order for the participant to be on the diet, and any reassessment of these criteria will be solely standard care, for clinical purposes:

• 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

Trial design

2 participants in 2 patient groups

Diet Group

Description:

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

Treatment:

Other: Modified Atkins Diet

Control Group

Description:

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.