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Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
NCT03949296 · View on ClinicalTrials.gov ↗
Study Summary
Purpose To determine whether Mindfulness-Based Treatment for Insomnia (MBTI) is more effective in the treatment of chronic insomnia disorder (CID) in patients with multiple sclerosis (MS) when compared with standard sleep hygiene counseling. Specific Aims / Hypotheses Our specific aims are to determine: * Whether MBTI is more effective than standard sleep hygiene counseling in improving objectively-measured sleep quality among this group of MS patients with CID, as measured by the Fitbit Charge 2 activity tracker. * Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported sleep quality among this group of MS patients with CID, as measured by the Pittsburgh Sleep Quality Index (PSQI). * Whether MTBI is more effective than standard sleep hygiene counseling in reducing self-reported severity of insomnia among this group of MS patients with CID, as measured by the Insomnia Severity Index (ISI). * Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported quality of life among this group of MS patients with CID, as measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI). We hypothesize that among study participants with MS and CID: * MBTI will improve their objectively-measured sleep quality, as measured by the Fitbit Charge 2 activity tracker. * MBTI will improve their self-reported sleep quality, as measured by the PSQI. * MBTI will reduce their self-reported severity of insomnia, as measured by the ISI. * Improvement in sleep quality and reduction in insomnia severity will result in improvement in self-reported quality of life, as measured by MSQLI scores. * MBTI will be superior to sleep hygiene counseling in improving sleep quality, reducing insomnia severity, and improving quality of life.
Conditions Studied
Interventions
- BEHAVIORAL Sleep Hygiene
- BEHAVIORAL Mindfulness Intervention
Study Locations (1)
Connecticut
- Yale-Griffin Prevention Research Center — Derby
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2019-12-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03949296
The ClinicalTrials.gov registry entry for NCT03949296 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Griffin Hospital, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Sleep Hygiene is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03949296 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03949296 about?
NCT03949296 is a clinical study titled "Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis". Purpose To determine whether Mindfulness-Based Treatment for Insomnia (MBTI) is more effective in the treatment of chronic insomnia disorder (CID) in patients with multiple sclerosis (MS) when compared with standard sleep hygiene counseling. Specific Aims / Hypotheses Our specific aims are to dete...
What is the current status of trial NCT03949296?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2017-12-11. Estimated completion is 2019-12-16.
What conditions does trial NCT03949296 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Insomnia Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03949296?
The interventions under investigation include: Sleep Hygiene (BEHAVIORAL), Mindfulness Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03949296?
This trial is sponsored by Griffin Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03949296 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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