Clinical trial NCT04193891: The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy
Official title: The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy: a Pilot Study.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Epilepsy
Seizures
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Institute for Clinical and Translational Research
name: National Institutes of Health (NIH)
First posted: 2019-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Epworth Sleepiness Scale
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Morning-Eveningness Questionnaire
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Mean Sleep Time Per Night
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Sleep Change Composition
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Sleep Latency
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Number of Awakenings per Night
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
measure: Change in Sleep Depth
timeFrame: before entering the study, 4-6 weeks after being on the diet (or 4-6 weeks after enrollment for control subjects)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Elizabeth Felton, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.