The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

August 12, 2025 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving care in the epilepsy clinics at the University of Wisconsin School of Medicine and Public Health.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Diet Group
Participants choosing to newly initiate the modified Atkins diet, a high fat low carb diet, for improved epilepsy control.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Epworth Sleepiness Scale
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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.
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Pittsburgh Sleep Quality Index
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
The Pittsburgh Sleep Quality Index measures participant quality of sleep in each of 7 domains over the last month: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total possible range of scores is 0-21 with 0 indicating no difficulties and 21 indicating severe difficulties.
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Morning-Eveningness Questionnaire
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
The Morning-Eveningness Questionnaire is a 19-item survey that measures participant tendency toward being a 'morning' or 'evening' person. The total possible range of scores is 16-86 with scores of 41 and below indicating 'evening' types, scores between 42-58 being 'intermediate' types, and scores of 59 and above 'morning' types.
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Mean Sleep Time Per Night
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Measured via Fitbit and per participant sleep log report between four nights at baseline and four nights at follow-up
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Sleep Change Composition
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Using the Prodigy sleep system (Cerebra Health Inc.), which uses EEG, Electromyography (EMG), and Electrooculogram (EOG) to measure sleep, we will determine the amount of time spent in the various stages of sleep (REM, Non-Rapid Eye Movement (NREM) Stage 1, NREM Stage 2, NREM Stage 3)
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Sleep Latency
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Sleep latency is the time it takes to fall asleep. This will be measured using the Prodigy sleep system (Cerebra Health Inc.) using EEG, EMG, and EOG
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Number of Awakenings per Night
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
This is the amount of times a participant is recorded as awake via the Prodigy (Cerebra Health Inc.) sleep system, according to EEG, EMG and EOG.
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Change in Sleep Depth
Time Frame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Sleep depth is a metric developed and patented by the company that is the maker of the Prodigy sleep system (Cerebra Health Inc.). It is a metric that estimates the ratio of time spent in light and deep sleep.
before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
Wisconsin Institute for Clinical and Translational Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Felton, MD/PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-1033
  • A535100 (Other Identifier: UW Madison)
  • SMPH/NEUROLOGY/NEUROLOGY (Other Identifier: UW Madison)
  • 5UL1TR002373-03 (U.S. NIH Grant/Contract)
  • Protocol Version 3/8/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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