Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). 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.
Primary Outcome
The PSQI is a 9-item participant-reported measure that assesses sleep quality. Scores range from 0 to 21 points, with higher scores indicating poorer sleep quality. Scores ≥ 5 are clinically significant.
Interventions
- BEHAVIORAL iSLEEPms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2022-04-20 |
| Phase | NA |
What the finished NCT04147052 record still lists
NCT04147052 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which iSLEEPms is the first listed.
NCT04147052 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04147052's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI