EpilepsyNCT04193891
The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy
An observational study of Epilepsy and Seizures, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- Modified Atkins Diet
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 26 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
Study population: Patients receiving care in the epilepsy clinics at the University of Wisconsin School of Medicine and Public Health.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Modified Atkins Diet
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet Group | Participants choosing to newly initiate the modified Atkins diet, a high fat low carb diet, for improved epilepsy control. Receives: Other: Modified Atkins Diet | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Scale
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measured via Fitbit and per participant sleep log report between four nights at baseline and four nights at follow-up
Measured: 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
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)
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start12 Feb 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Why it stopped: due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Institute for Clinical and Translational Research, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Felton, MD/PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193891
- Sponsor's protocol ID
- 2019-1033
- Other IDs
- A535100, SMPH/NEUROLOGY/NEUROLOGY, 5UL1TR002373-03, Protocol Version 3/8/2020
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2019
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26198999
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04193891
- Acronym / sponsor ID
- 2019-1033
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to COVID-19
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Institute for Clinical and Translational Research, National Institutes of Health (NIH)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Group | – | Other: Modified Atkins DietParticipants choosing to newly initiate the modified Atkins diet, a high fat low carb diet, for improved epilepsy control. |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care in the epilepsy clinics at the University of Wisconsin School of Medicine and Public Health.
Key inclusion criteria (3 listed)
- Diagnosis of epilepsy
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Atkins DietThe 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. | Other | Diet Group |
Primary outcome
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.
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.
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.
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
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)
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
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.
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.
Results and safety
The study was stopped early (reason given: due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 26198999Felton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Felton, MD/PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Seizures, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.