Insomnia ChronicNCT03949296

Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

A study testing Mindfulness Intervention and Sleep Hygiene in people with Insomnia Chronic and Multiple Sclerosis, run by Griffin Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia Chronic, Multiple Sclerosis
What is being tested?: Mindfulness Intervention and Sleep Hygiene
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2017to 16 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women age 18 years or older
Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria
Moderate to severe insomnia based on Insomnia Severity Index score
Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0
Stable medications and disease activity for the past 30 days
Willingness to visit Griffin Hospital for up to 13 times if assigned to the mindfulness group, or up to 4 times if assigned to the sleep hygiene group, for study assessment and counseling or educational sessions

Who cannot join

Diagnosis of obstructive sleep apnea or narcolepsy
High risk of obstructive sleep apnea, as determined by the STOP-Bang questionnaire, if no known diagnosis of sleep apnea
Significant pulmonary, cardiac, hepatic or other medical conditions
Relapse of MS symptoms within the 30 days prior to study entry
Use of corticosteroids, either IV or oral, for exacerbations of symptoms
Inability to comply with the protocol
A lack of proficiency in reading, writing in, and understanding English
Body mass index (BMI) > 39 (350 lb. due to the limitations of the scale used for the study)

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

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.

Read the detailed description

BACKGROUND:

An estimated 25 to 40 percent of individuals with multiple sclerosis (MS) suffer from chronic insomnia, and the prevalence of sleep disorders is often unrecognized. Chronic insomnia disorder (CID) is defined as persistent difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity and circumstances for sleep, leading to daytime impairment, and ongoing for at least three consecutive months.

Common causes of CID in MS include motor disorders such as cramps, spasms, restless leg syndrome and periodic limb movements, neuropathic pain, bladder dysfunction (such as nocturia), and obstructive sleep apnea. Depression, anxiety, daytime fatigue, and cognitive dysfunction are also associated with sleep disorders in MS. Moreover, treatments for the underlying disease, such as interferon therapy, as well as treatments for various symptoms of MS, such as stimulant medications used to treat fatigue, may also contribute to insomnia.

Many patients manage their insomnia using benzodiazepines and other medications, which may be associated with a number of adverse effects, including dependence and tolerance, cognitive dysfunction, and depression. Furthermore, other adverse effects of benzodiazepines arise from their use in combination with other drugs such as opioid narcotics for pain. Therefore, it is desirable to find effective nonpharmacological treatments for insomnia in patients with multiple sclerosis.

Psychologically-based and behavioral treatments have been widely tested in various cohorts of patients with CID with and without co-morbid conditions. These methods include cognitive behavioral therapies (CBT), sleep hygiene programs, mindfulness meditation, and others. In a randomized controlled clinical trial of 72 women with CID and MS in Iran, CBT treatment was associated with improved sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). A case series of 11 patients with chronic insomnia and MS who were treated with CBT at the Cleveland Clinic Sleep Disorders Center improved on measures of insomnia, fatigue and depression, as well as an increase in total sleep time of 1.5 hours.

Mindfulness based stress reduction (MBSR) is an empirically-supported intervention designed to decrease stress, chronic and acute pain and anxiety in adults. Mindfulness is the practice of focusing full attention on the present moment intentionally and without judgment. The practice of mindfulness is hypothesized to reduce feelings of distress and stress reactivity by increasing one's awareness of and ability to tolerate thoughts and emotions. Mindfulness may help individuals decrease distress and over-reactivity to events and increase the ability to respond to events in ways that one consciously chooses (rather than through automatic 'mindless" behaviors). Mindfulness-based interventions such as MBSR teach mindfulness through meditation, yoga, present-minded awareness in everyday life, and discussions of stress physiology and coping.

Several studies have demonstrated the effectiveness of MBSR interventions in the treatment of insomnia. Long-term meditators have been shown to have increased parietal-occipital gamma (25-40 Hz) during NREM (non-rapid eye movement sleep), showing that MBSR can induce objective changes in sleep architecture. MBSR and MBTI (mindfulness based treatment of insomnia) have been shown in randomized, controlled studies to decrease sleep latency and total waking time and increase sleep time.These effects, moreover, have been durable. However, a meta-analysis of 6 randomized controlled trials involving 330 participants showed that mindfulness meditation significantly improved total wake time and sleep quality, but had no significant effects on sleep onset latency, total sleep time, wake after sleep onset, sleep efficiency, total wake time, Insomnia Severity Index (ISI), PSQI, or Dysfunctional Beliefs and Attitudes Sleep Scale (DBAS).

Mindfulness training has been shown to be beneficial in improving several symptoms of MS, including those that have been shown to impact sleep. A randomized, controlled study of 150 patients undergoing mindfulness training showed improvements in quality of life and well-being, including fatigue and depression. Furthermore, there is Class 1 evidence that stress reduction in MS can affect the underlying inflammatory biology of MS, as evidenced by a reduction in new MRI lesions. However, many other studies showing benefits of stress reduction in MS are limited by their descriptive nature and non-controlled design.

The significance of this study is that while there are data showing the effectiveness of mindfulness-based techniques in treating insomnia in general, and some data showing the benefits of using non-mindfulness stress reduction techniques in the management of MS-related insomnia, there have been no studies to date on the efficacy of mindfulness techniques in treating MS-related insomnia.

Conditions: Insomnia Chronic, Multiple Sclerosis
Being tested: Mindfulness Intervention, Sleep Hygiene
Medical subject headings: Sleep Initiation and Maintenance Disorders, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness InterventionBehavioural
10-session program
1. Introduction to mindfulness and its potential benefits
2. Introduction to mindful practices and yoga poses
3. Conditioned reactions to stress; integrating mindfulness into everyday life
4. Challenges and insights gained in practicing mindfulness
5. Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses
6. Reacting vs. responding to stressors
7. Self-regulation and coping with stressors and communication challenges
8. Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness
9. Choosing and creating one's own blend of mindfulness practices
10. Maintaining momentum to practice mindfulness once the program ends
Sleep HygieneBehavioural
Session includes a handout with15 sleep hygiene tips:
1. Maintain a regular sleep pattern
2. Only try to sleep when feeling tired or sleepy
3. If unable to sleep, do something calm until feeling tired and returning to bed
4. Avoid caffeine \& nicotine for 4-6 hours before going to bed
5. Avoid alcohol for 4-6 hours before going to bed
6. Use the bed only for sleeping and sex
7. Avoid naps during the day
8. Develop rituals to get relaxed and ready to sleep
9. Try a hot bath prior to bedtime
10. Avoid checking the clock during the night
11. Use a sleep diary for a few weeks to track progress
12. Avoid strenuous exercise before bedtime
13. Avoid a heavy meal before bedtime
14. Create a sleep environment that is quiet, comfortable, and dark
15. Maintain a regular daytime routine

Study groups in NCT03949296
Study group	Role	What they receive
Mindfulness Intervention	Active comparator	Mindfulness-Based Treatment for Insomnia intervention led by a certified instructor. It is adapted from the Mindfulness-Based Stress Reduction Curriculum developed by the Center for Mindfulness in Medicine, Health Care, and Society at the University of Massachusetts Medical School. It introduces the concept of mindfulness and provides the opportunity to practice it within sessions and during home practice. Participants learn about stress, and explore habitual behavioral, physical, emotional and cognitive patterns, as well as more effective responses to challenges and demands of everyday life. Each class includes mindfulness practice, group discussions, and practices and exercises related to the class topics. Participants receive home assignments with guided meditation and yoga practices. Receives: Behavioral: Mindfulness Intervention
Sleep Hygiene	Placebo comparator	Control group participants attend a 30-minute group counseling session on sleep hygiene. The session includes a handout from the Centre for Clinical Intervention in Australia that provides 15 sleep hygiene tips. Receives: Behavioral: Sleep Hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Quality
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 post-intervention data; and the last week of the 4-month post-intervention period will be used to assess the sustainability of the intervention. Data from the remaining weeks of the 10-week intervention and 4-month post-intervention periods will be used to examine whether participants experience an upward trend in sleep quality during the course of the study.
Measured: 4 months

Secondary outcomes (2)

Self-Reported Sleep Quality
Self-reported sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, at the end of the 10-week intervention, and at 4 months post-intervention. The PSQI is a self-rated questionnaire to assess perceived sleep quality and disturbances over a 1-month time interval. This 19-item instrument uses a Likert scale (ranging from 0 to 3) to assess 7 clinically derived domains of sleep: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" vs. "poor" sleepers. A global score > 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p < 0.001) in distinguishing good vs. poor sleepers.
Measured: 4 months
Self-Reported Quality of Life
Self-reported quality of life will be measured at baseline, the end of the 10-week intervention, and 4 months post-intervention using the Multiple Sclerosis Quality of Life Index (MSQLI). The MSQLI includes a set of 10 questionnaires to provide a quality of life measure that is both generic and MS-specific. The questionnaires assess health status, fatigue, pain, sexual satisfaction, bladder control, bowel control, visual impairment, perceived deficits, mental health, and social support. Each individual scale generates a separate score. There is no global composite combining all the scales into a single score. There is good internal consistency reliability for the subscales of the MSQLI, with the lowest alpha being 0.67 (for social functioning on SF-36). Other coefficients range from 0.78 (BWCS) to 0.97 (MSSS). Test-retest reliability on the SF-36 ranges from 0.60 (social functioning) to 0.81 (physical functioning).
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 201716 Dec 2019

First posted14 May 2019
Study start11 Dec 2017
Primary completion16 Dec 2019
Study completion16 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (47)Papers the sponsor has linked to this study.
Other trials for Insomnia ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A placebo-controlled, randomized, single-blinded clinical study involving a projected 90 participants with multiple sclerosis in a 50:50 randomization scheme.
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03949296
Sponsor's protocol ID: 2017-01
Status last verified: Feb 2020
First submitted: 29 Dec 2018
Last updated: 26 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Viana P, Rodrigues E, Fernandes C, Matas A, Barreto R, Mendonca M, Peralta R, Geraldes R. InMS: Chronic insomnia disorder in multiple sclerosis - a Portuguese multicentre study on prevalence, subtypes, associated factors and impact on quality of life. Mult Scler Relat Disord. 2015 Sep;4(5):477-483. doi: 10.1016/j.msard.2015.07.010. Epub 2015 Jul 26.
PubMed 26346798
Veauthier C, Radbruch H, Gaede G, Pfueller CF, Dorr J, Bellmann-Strobl J, Wernecke KD, Zipp F, Paul F, Sieb JP. Fatigue in multiple sclerosis is closely related to sleep disorders: a polysomnographic cross-sectional study. Mult Scler. 2011 May;17(5):613-22. doi: 10.1177/1352458510393772. Epub 2011 Jan 28.
PubMed 21278050
Veauthier C, Paul F. Sleep disorders in multiple sclerosis and their relationship to fatigue. Sleep Med. 2014 Jan;15(1):5-14. doi: 10.1016/j.sleep.2013.08.791. Epub 2013 Nov 15.
PubMed 24360534
Braley TJ, Segal BM, Chervin RD. Obstructive sleep apnea and fatigue in patients with multiple sclerosis. J Clin Sleep Med. 2014 Feb 15;10(2):155-62. doi: 10.5664/jcsm.3442.
PubMed 24532998
Brass SD, Li CS, Auerbach S. The underdiagnosis of sleep disorders in patients with multiple sclerosis. J Clin Sleep Med. 2014 Sep 15;10(9):1025-31. doi: 10.5664/jcsm.4044.
PubMed 25142763
Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. No abstract available.
PubMed 25221449
Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.
PubMed 18207453
Stanton BR, Barnes F, Silber E. Sleep and fatigue in multiple sclerosis. Mult Scler. 2006 Aug;12(4):481-6. doi: 10.1191/135248506ms1320oa.
PubMed 16900762
Boe Lunde HM, Aae TF, Indrevag W, Aarseth J, Bjorvatn B, Myhr KM, Bo L. Poor sleep in patients with multiple sclerosis. PLoS One. 2012;7(11):e49996. doi: 10.1371/journal.pone.0049996. Epub 2012 Nov 14.
PubMed 23166808
Bamer AM, Johnson KL, Amtmann DA, Kraft GH. Beyond fatigue: Assessing variables associated with sleep problems and use of sleep medications in multiple sclerosis. Clin Epidemiol. 2010 May 1;2010(2):99-106. doi: 10.2147/CLEP.S10425.
PubMed 20838467
Italian REMS Study Group; Manconi M, Ferini-Strambi L, Filippi M, Bonanni E, Iudice A, Murri L, Gigli GL, Fratticci L, Merlino G, Terzano G, Granella F, Parrino L, Silvestri R, Arico I, Dattola V, Russo G, Luongo C, Cicolin A, Tribolo A, Cavalla P, Savarese M, Trojano M, Ottaviano S, Cirignotta F, Simioni V, Salvi F, Mondino F, Perla F, Chinaglia G, Zuliani C, Cesnik E, Granieri E, Placidi F, Palmieri MG, Manni R, Terzaghi M, Bergamaschi R, Rocchi R, Ulivelli M, Bartalini S, Ferri R, Lo Fermo S, Ubiali E, Viscardi M, Rottoli M, Nobili L, Protti A, Ferrillo F, Allena M, Mancardi G, Guarnieri B, Londrillo F. Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study. Sleep. 2008 Jul;31(7):944-52.
PubMed 18655317
Braley TJ, Segal BM, Chervin RD. Sleep-disordered breathing in multiple sclerosis. Neurology. 2012 Aug 28;79(9):929-36. doi: 10.1212/WNL.0b013e318266fa9d. Epub 2012 Aug 15.
PubMed 22895593
Pokryszko-Dragan A, Bilinska M, Gruszka E, Biel L, Kaminska K, Konieczna K. Sleep disturbances in patients with multiple sclerosis. Neurol Sci. 2013 Aug;34(8):1291-6. doi: 10.1007/s10072-012-1229-0. Epub 2012 Oct 30.
PubMed 23109097
Mendozzi L, Tronci F, Garegnani M, Pugnetti L. Sleep disturbance and fatigue in mild relapsing remitting multiple sclerosis patients on chronic immunomodulant therapy: an actigraphic study. Mult Scler. 2010 Feb;16(2):238-47. doi: 10.1177/1352458509354551. Epub 2009 Dec 22.
PubMed 20028705
Lanza G, Ferri R, Bella R, Ferini-Strambi L. The impact of drugs for multiple sclerosis on sleep. Mult Scler. 2017 Jan;23(1):5-13. doi: 10.1177/1352458516664034. Epub 2016 Aug 19.
PubMed 27503906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
ClinicalTrials.gov ID: NCT03949296
Acronym / sponsor ID: 2017-01
Conditions: Insomnia Chronic, Multiple Sclerosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Griffin HospitalUniversity, hospital or other
Collaborators: Yale-Griffin Prevention Research Center, Yale University
Study start: 11 Dec 2017 (actual)
Primary completion: 16 Dec 2019 (actual)
Study completion: 16 Dec 2019 (actual)
First posted: 14 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

BACKGROUND:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A placebo-controlled, randomized, single-blinded clinical study involving a projected 90 participants with multiple sclerosis in a 50:50 randomization scheme.

Arm	Type	Receives
Mindfulness Intervention	Active comparator	Behavioral: Mindfulness InterventionMindfulness-Based Treatment for Insomnia intervention led by a certified instructor. It is adapted from the Mindfulness-Based Stress Reduction Curriculum developed by the Center for Mindfulness in Medicine, Health Care, and Society at the University of Massachusetts Medical School. It introduces the concept of mindfulness and provides the opportunity to practice it within sessions and during home practice. Participants learn about stress, and explore habitual behavioral, physical, emotional and cognitive patterns, as well as more effective responses to challenges and demands of everyday life. Each class includes mindfulness practice, group discussions, and practices and exercises related to the class topics. Participants receive home assignments with guided meditation and yoga practices.
Sleep Hygiene	Placebo comparator	Behavioral: Sleep HygieneControl group participants attend a 30-minute group counseling session on sleep hygiene. The session includes a handout from the Centre for Clinical Intervention in Australia that provides 15 sleep hygiene tips.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men and women age 18 years or older
Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria
Moderate to severe insomnia based on Insomnia Severity Index score
Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0
Stable medications and disease activity for the past 30 days

Key exclusion criteria (8 listed)

Diagnosis of obstructive sleep apnea or narcolepsy
High risk of obstructive sleep apnea, as determined by the STOP-Bang questionnaire, if no known diagnosis of sleep apnea
Significant pulmonary, cardiac, hepatic or other medical conditions
Relapse of MS symptoms within the 30 days prior to study entry
Use of corticosteroids, either IV or oral, for exacerbations of symptoms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness Intervention10-session program 1. Introduction to mindfulness and its potential benefits 2. Introduction to mindful practices and yoga poses 3. Conditioned reactions to stress; integrating mindfulness into everyday life 4. Challenges and insights gained in practicing mindfulness 5. Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses 6. Reacting vs. responding to stressors 7. Self-regulation and coping with stressors and communication challenges 8. Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness 9. Choosing and creating one's own blend of mindfulness practices 10. Maintaining momentum to practice mindfulness once the program ends	Behavioural	Mindfulness Intervention
Sleep HygieneSession includes a handout with15 sleep hygiene tips: 1. Maintain a regular sleep pattern 2. Only try to sleep when feeling tired or sleepy 3. If unable to sleep, do something calm until feeling tired and returning to bed 4. Avoid caffeine \& nicotine for 4-6 hours before going to bed 5. Avoid alcohol for 4-6 hours before going to bed 6. Use the bed only for sleeping and sex 7. Avoid naps during the day 8. Develop rituals to get relaxed and ready to sleep 9. Try a hot bath prior to bedtime 10. Avoid checking the clock during the night 11. Use a sleep diary for a few weeks to track progress 12. Avoid strenuous exercise before bedtime 13. Avoid a heavy meal before bedtime 14. Create a sleep environment that is quiet, comfortable, and dark 15. Maintain a regular daytime routine	Behavioural	Sleep Hygiene

Primary outcome

Sleep Quality
Time frame: 4 months
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 post-intervention data; and the last week of the 4-month post-intervention period will be used to assess the sustainability of the intervention. Data from the remaining weeks of the 10-week intervention and 4-month post-intervention periods will be used to examine whether participants experience an upward trend in sleep quality during the course of the study.

2 secondary outcomes

Self-Reported Sleep Quality
Time frame: 4 months
Self-Reported Quality of Life
Time frame: 4 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Background: PubMed 26346798Viana P, Rodrigues E, Fernandes C, Matas A, Barreto R, Mendonca M, Peralta R, Geraldes R. InMS: Chronic insomnia disorder in multiple sclerosis - a Portuguese multicentre study on prevalence, subtypes, associated factors and impact on quality of life. Mult Scler Relat Disord. 2015 Sep;4(5):477-483. doi: 10.1016/j.msard.2015.07.010. Epub 2015 Jul 26.
Background: PubMed 21278050Veauthier C, Radbruch H, Gaede G, Pfueller CF, Dorr J, Bellmann-Strobl J, Wernecke KD, Zipp F, Paul F, Sieb JP. Fatigue in multiple sclerosis is closely related to sleep disorders: a polysomnographic cross-sectional study. Mult Scler. 2011 May;17(5):613-22. doi: 10.1177/1352458510393772. Epub 2011 Jan 28.
Background: PubMed 24360534Veauthier C, Paul F. Sleep disorders in multiple sclerosis and their relationship to fatigue. Sleep Med. 2014 Jan;15(1):5-14. doi: 10.1016/j.sleep.2013.08.791. Epub 2013 Nov 15.
Background: PubMed 24532998Braley TJ, Segal BM, Chervin RD. Obstructive sleep apnea and fatigue in patients with multiple sclerosis. J Clin Sleep Med. 2014 Feb 15;10(2):155-62. doi: 10.5664/jcsm.3442.
Background: PubMed 25142763Brass SD, Li CS, Auerbach S. The underdiagnosis of sleep disorders in patients with multiple sclerosis. J Clin Sleep Med. 2014 Sep 15;10(9):1025-31. doi: 10.5664/jcsm.4044.
Background: PubMed 25221449Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. No abstract available.
Background: PubMed 18207453Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.
Background: PubMed 16900762Stanton BR, Barnes F, Silber E. Sleep and fatigue in multiple sclerosis. Mult Scler. 2006 Aug;12(4):481-6. doi: 10.1191/135248506ms1320oa.
Background: PubMed 23166808Boe Lunde HM, Aae TF, Indrevag W, Aarseth J, Bjorvatn B, Myhr KM, Bo L. Poor sleep in patients with multiple sclerosis. PLoS One. 2012;7(11):e49996. doi: 10.1371/journal.pone.0049996. Epub 2012 Nov 14.
Background: PubMed 20838467Bamer AM, Johnson KL, Amtmann DA, Kraft GH. Beyond fatigue: Assessing variables associated with sleep problems and use of sleep medications in multiple sclerosis. Clin Epidemiol. 2010 May 1;2010(2):99-106. doi: 10.2147/CLEP.S10425.
Background: PubMed 18655317Italian REMS Study Group; Manconi M, Ferini-Strambi L, Filippi M, Bonanni E, Iudice A, Murri L, Gigli GL, Fratticci L, Merlino G, Terzano G, Granella F, Parrino L, Silvestri R, Arico I, Dattola V, Russo G, Luongo C, Cicolin A, Tribolo A, Cavalla P, Savarese M, Trojano M, Ottaviano S, Cirignotta F, Simioni V, Salvi F, Mondino F, Perla F, Chinaglia G, Zuliani C, Cesnik E, Granieri E, Placidi F, Palmieri MG, Manni R, Terzaghi M, Bergamaschi R, Rocchi R, Ulivelli M, Bartalini S, Ferri R, Lo Fermo S, Ubiali E, Viscardi M, Rottoli M, Nobili L, Protti A, Ferrillo F, Allena M, Mancardi G, Guarnieri B, Londrillo F. Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study. Sleep. 2008 Jul;31(7):944-52.
Background: PubMed 22895593Braley TJ, Segal BM, Chervin RD. Sleep-disordered breathing in multiple sclerosis. Neurology. 2012 Aug 28;79(9):929-36. doi: 10.1212/WNL.0b013e318266fa9d. Epub 2012 Aug 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph B Guarnaccia, MD principal investigator

Griffin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Intervention and Sleep Hygiene in people with Insomnia Chronic and Multiple Sclerosis, run by Griffin Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949296, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.