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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 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.

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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).

Conditions Studied

Multiple Sclerosis Insomnia

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

FieldValue
Enrollment Target 70 participants
Start Date 2024-07-30
Est. Completion 2027-05-31
Phase Phase 2

Sponsor

University of Kansas Medical Center

408 total trials

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What the Registry Record Tells You About NCT06428006

The ClinicalTrials.gov registry entry for NCT06428006 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (88% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.