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NCT06434571 · ClinicalTrials.gov registry record · Phase 2
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
A Phase 2 study of Multiple Sclerosis and Insomnia, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06434571: Recruiting Phase 2 study of Multiple Sclerosis and Insomnia, sponsored by University of Kansas Medical Center.
NCT06434571 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 90 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06434571, 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
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
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 Treatment as usual (TAU)
- BEHAVIORAL Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
- BEHAVIORAL Web-based cognitive behavioral therapy for insomnia (wCBT-I)
Study Locations (1)
Kansas
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-10-11 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT06434571 shows while recruiting
NCT06434571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Treatment as usual (TAU) is the first listed.
NCT06434571 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06434571 about?
NCT06434571 is a clinical study titled "Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection". The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the ch...
What is the current status of trial NCT06434571?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-10-11. Estimated completion is 2028-07-31.
What conditions does trial NCT06434571 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Insomnia.
What interventions are being tested in trial NCT06434571?
The interventions under investigation include: Treatment as usual (TAU) (BEHAVIORAL), Telehealth cognitive behavioral therapy for insomnia (tCBT-I) (BEHAVIORAL), Web-based cognitive behavioral therapy for insomnia (wCBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06434571?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06434571 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 NCT06434571's enrollment target sits among peer trials
90 137th of 315 higher than 177 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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