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NCT03949296 · ClinicalTrials.gov registry record · NA

Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

A NA study of Multiple Sclerosis and Insomnia Chronic, sponsored by Griffin Hospital.

Completed
Registry status
NA
Development phase
49
Enrollment target
1
Study location

NCT03949296: Completed NA study of Multiple Sclerosis and Insomnia Chronic, sponsored by Griffin Hospital.

NCT03949296 is a NA study of Multiple Sclerosis and Insomnia Chronic that has completed, run by Griffin Hospital. The registered enrollment target is 49 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03949296, a NA study of Multiple Sclerosis and Insomnia Chronic, has completed, sponsored by Griffin Hospital.

COMPLETED
Registry status
NA
Development phase
49 participants
Enrollment target
1
Study location

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.

Primary Outcome

Objective sleep quality will be measured using a Fitbit Charge activity monitor to be worn daily during the 10-week intervention, and daily during a 4-month post-intervention period. For the purpose of assessing the impact of the intervention on objective sleep quality, the first week of Fitbit sleep data collected during the 10-week intervention (i.e., during the week of the mindfulness orientation session) will count as baseline data; the last week of the 10-week intervention will count as pos

Interventions

  • BEHAVIORAL Sleep Hygiene
  • BEHAVIORAL Mindfulness Intervention

Study Locations (1)

Connecticut

  • Yale-Griffin Prevention Research Center - Derby

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2017-12-11
Est. Completion 2019-12-16
Phase NA
Griffin Hospital

22 total trials

What the finished NCT03949296 record still lists

NCT03949296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower).

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.

NCT03949296 reports a single indexed study location in Connecticut.

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.

What interventions are being tested in trial NCT03949296?

The interventions under investigation include: Sleep Hygiene (BEHAVIORAL), Mindfulness Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03949296?

This trial is sponsored by Griffin Hospital, which has 22 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03949296's enrollment target sits among peer trials

49 186th of 315 higher than 130 of 315 other Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis 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

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Source: ClinicalTrials.gov NCT03949296, the US trial registry maintained by the National Library of Medicine. NCT03949296 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.