The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy

NCT04193891 | Terminated

• 5 other identifiers: 2019-1033A535100SMPH/NEUROLOGY/NEUROLOGY5UL1TR002373-03Protocol Version 3/8/2020
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizures

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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

  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)

  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

  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.

  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.

  before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)

Study Arms (2)

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

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.

Interventions

Modified Atkins Diet OTHER

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.

Diet Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Institute for Clinical and Translational Research: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• 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.

  PMID: 26198999 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Felton, MD/PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: February 12, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)