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The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

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ClinicalTrials.gov Identifier: NCT04193891
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Wisconsin Institute for Clinical Research
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Epilepsy Seizures Other: Modified Atkins Diet

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy: a Pilot Study.
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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)

  6. 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

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193891


Contacts
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Contact: Sara E Berman, PhD 8456421712 seberman@wisc.edu
Contact: Elizabeth Felton, MD/PhD 6082630755 felton@neurology.wisc.edu

Sponsors and Collaborators
University of Wisconsin, Madison
Wisconsin Institute for Clinical Research
Investigators
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Principal Investigator: Elizabeth Felton, MD/PhD University of Wisconsin, Madison

Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04193891    
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 )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms