Who is eligible for clinical trial NCT06428006?

Participants must meet protocol criteria for Multiple Sclerosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06428006 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-09

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis (NCT06428006)

🟢 Recruiting Phase2 🧠 Behavioral & Psychological Program Sponsor: University of Kansas Medical Center

🩺 Plain-English Summary (8th-Grade Level)

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (17 items).

Location: University of Kansas Medical Center — Kansas City, Kansas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

18-65 years old
Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 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 at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as 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 reading ability 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

Usually NOT eligible if any of the following apply:

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 or agonists for insomnia
Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression 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 indicated by 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Kansas Medical Center — Kansas City, Kansas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗