- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193891
The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy
June 14, 2023 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
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
Observational
Enrollment (Estimated)
20
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
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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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
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 |
Intervention / Treatment |
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Diet Group
Participants choosing to newly initiate the modified Atkins diet, a high fat low carb diet, for improved epilepsy control.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
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)
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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.
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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.
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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.
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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Measured via Fitbit and per participant sleep log report between four nights at baseline and four nights at follow-up
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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)
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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.
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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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)
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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.
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before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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.
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)
February 12, 2020
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 4, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (Actual)
December 10, 2019
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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