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NCT06428006 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
A Phase 2 study of Multiple Sclerosis and Insomnia, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06428006: Recruiting Phase 2 study of Multiple Sclerosis and Insomnia, sponsored by University of Kansas Medical Center.
NCT06428006 is a Phase 2 study of Multiple Sclerosis and Insomnia that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 70 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06428006, a Phase 2 study of Multiple Sclerosis and Insomnia, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive behavioral therapy for insomnia
- BEHAVIORAL Sleep and lifestyle education
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-07-30 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What NCT06428006 shows while recruiting
NCT06428006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Cognitive behavioral therapy for insomnia is the first listed.
NCT06428006 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06428006 about?
NCT06428006 is a clinical study titled "Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis". 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 functi...
What is the current status of trial NCT06428006?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-07-30. Estimated completion is 2027-05-31.
What conditions does trial NCT06428006 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Insomnia.
What interventions are being tested in trial NCT06428006?
The interventions under investigation include: Cognitive behavioral therapy for insomnia (BEHAVIORAL), Sleep and lifestyle education (BEHAVIORAL).
Who is sponsoring clinical trial NCT06428006?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06428006 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06428006's enrollment target sits among peer trials
70 154th of 315 higher than 160 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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