Talking your way to better sleep with MS?
NCT ID NCT06428006
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and reduce fatigue in people with multiple sclerosis. About 70 adults with MS and insomnia will receive CBT-I or an active control. The goal is to see if this talk therapy approach can ease insomnia symptoms and boost quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cognitive behavioral therapy for insomnia (CBT-I)
- What this could lead to
- If it works, this could provide a non-drug way to improve sleep and reduce fatigue in people with multiple sclerosis.
- What could go wrong
- This is a small, early-phase trial with only 70 participants. Results may not apply to everyone with MS, and the therapy requires time and effort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 * Severe mental illness such as schizophrenia or bipolar disorder * Severe neurological or sensory impairments that would interfere significantly with testing * Relapse and/or corticosteroid use in the past 8 weeks * History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am * Currently receiving a behavioral sleep health intervention
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Insomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise rebuild muscle and balance in MS?
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Can diet ease the crushing fatigue of multiple sclerosis?
- One-Time CAR-T infusion tested against progressive MS
- Can PET scans reveal hidden brain inflammation in MS?