NCT06434571 Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
| NCT ID | NCT06434571 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Kansas Medical Center |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-10-11 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 18-65 years old * Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 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 Telephone Interview of Cognitive Status * 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 * If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06434571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06434571 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06434571 currently recruiting?
Yes, NCT06434571 is actively recruiting participants. Contact the research team at enelson5@kumc.edu for enrollment information.
Where is the NCT06434571 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06434571 clinical trial?
NCT06434571 is sponsored by University of Kansas Medical Center. The trial plans to enroll 90 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.