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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06434571
The ClinicalTrials.gov registry entry for NCT06434571 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 90 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 (85% 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 3 interventions - of which Treatment as usual (TAU) is the first listed.
NCT06434571 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.