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NCT04147052 · ClinicalTrials.gov registry record · NA
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT04147052: Completed NA study, sponsored by Johns Hopkins University.
NCT04147052 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04147052, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes. This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials. The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.
Interventions
- BEHAVIORAL iSLEEPms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2022-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04147052
The ClinicalTrials.gov registry entry for NCT04147052 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which iSLEEPms is the first listed.
NCT04147052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04147052 about?
NCT04147052 is a clinical study titled "iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis". Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease)...
What is the current status of trial NCT04147052?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2021-09-03. Estimated completion is 2022-04-20.
What interventions are being tested in trial NCT04147052?
The interventions under investigation include: iSLEEPms (BEHAVIORAL).
Who is sponsoring clinical trial NCT04147052?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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