Phase
Condition
Insomnia
Multiple Sclerosis
Memory Loss
Treatment
Sleep and lifestyle education
Cognitive behavioral therapy for insomnia
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18-65 years old
Diagnosis of relapsing-remitting or secondary progressive MS based on establishedguidelines20 and verified by their neurologist
Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
Report of difficulty falling asleep, maintaining sleep, or waking up too early atleast 3 nights/week for the past 3 months with significant distress and impact onfunction despite adequate opportunity for sleep and not due to other sleep disordersas indicated in the DSM-5
≥10 on Insomnia Severity Index
English speaking
≥31 on modified Telephone Interview of Cognitive Status23
Has a high school diploma or equivalent to serve as a proxy measurement of readingability to ensure adequate reading ability to participate in the study
Report having access to internet service or a data plan and access to a computer,tablet, or smart phone
Exclusion
Exclusion Criteria:
Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
>3 on STOP BANG indicating increased risk of sleep apnea
Restless legs syndrome as determined by RLS-Diagnosis Index
Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
Parasomnia as determined by the Sleep Disorders-Revised
Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements oragonists for insomnia
Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severedepression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicatedby DSM-5 criteria
History of other nervous system disorder such as stroke or Parkinson's disease
Currently pregnant or intending to become pregnant in the next 6 months
Severe mental illness such as schizophrenia or bipolar disorder
Severe neurological or sensory impairments that would interfere significantly withtesting
Relapse and/or corticosteroid use in the past 8 weeks
History of (within 5 years) or currently conducting overnight shift work includinghours of midnight-4am
Currently receiving a behavioral sleep health intervention
Study Design
Connect with a study center
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
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