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Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04054050
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative strategy to reduce sleep disturbance in MS, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. This pilot study will evaluate whether, in people with MS, bright light therapy reduces sleep disturbance and explore whether light therapy improves function of these cells.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Light therapy Not Applicable

Detailed Description:
Multiple sclerosis (MS), an inflammatory and neurodegenerative disorder of the central nervous system (CNS), is the most common cause of progressive neurologic dysfunction in early to middle adulthood. People with MS are a markedly high risk for sleep disturbance. Estimates of the lifetime prevalence of sleep disturbance in MS reach 50%; sleep disturbance is also associated with excess MS-associated morbidity and diminished quality of life. Despite the high burden of impaired sleep and its contribution to adverse MS outcomes, effective approaches to treat and ameliorate disturbed sleep in people with MS remain poorly understood. There is unmet need to develop safe and effective rehabilitative alternatives to mitigate sleep disturbance in MS. Prior research supports the use of timed bright light therapy (LT) as one such approach for insomnia and sleepiness in those with sleep disorders or other neurologic diseases. Yet, the safety and potential effectiveness of timed LT have yet to be tested in MS. The goal of the proposed study is to conduct a detailed intervention study testing if timed bright LT in people with MS is 1) safe (primary outcome) and 2) potentially effective for reducing sleep disturbance (specifically, reducing insomnia, fatigue and improving sleep efficiency, quantity and quality as secondary outcomes). The study will also explore whether LT stimulates a novel subtype of retinal ganglion cells which are central to the regulation of circadian rhythms and sleep.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Light therapy
Participants receive one hour of morning (within 9:00am-11:00am) and afternoon/evening (within 5:00pm-7:00pm).
Other: Light therapy
Bright light (10,000 lux) therapy will be administered via a light box.




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 2 weeks ]
    The number of adverse events will be documented and categorized by organ system


Secondary Outcome Measures :
  1. Change in sleep quantity as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 2 weeks ]
    The PSQI has a sub-component that quantifies sleep quantity. The investigators will assess change in sleep quantity (difference in minutes) as assessed by this sub-component.

  2. Change in sleep efficiency as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 2 weeks ]
    The PSQI has a sub-component that quantifies sleep efficiency. The investigators will assess change in sleep efficiency (difference in minutes) as assessed by this sub-component.

  3. Change in overall sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 2 weeks ]
    The PSQI has an overall score that ranges from 0 to 21. The investigators will assess change in the overall PSQI score.

  4. Change in sleep efficiency as assessed by actigraphy [ Time Frame: Baseline, 2 weeks ]
    Change in sleep efficiency is calculated as time sleeping divided by time in bed which is measured by actigraphy.

  5. Change in total sleep time [ Time Frame: Baseline, 2 weeks ]
    Change in total sleep time (minutes) as quantified by actigraphy

  6. Change in insomnia severity as assessed by the Insomnia Severity Index (ISI) [ Time Frame: Baseline, 2 weeks ]
    The ISI is validated questionnaire assessing insomnia from which a total score is calculated and ranges from 0 to 28. The investigators will calculate change in the overall ISI score.

  7. Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, 2 weeks ]
    The ESS is validated questionnaire assessing daytime sleepiness from which a total score is calculated and ranges from 0 to 24. The investigators will calculate change in the overall ESS score.

  8. Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire [ Time Frame: Baseline, 2 weeks ]
    The Neuro-QoL fatigue severity score (short form) is a validated 8-question assessment of fatigue from which T-scores ranging from 0 to 100 can be obtained. The investigators will assess change in Neuro-QoL fatigue severity.

  9. Change in function of intrinsically photosensitive retinal ganglion cells [ Time Frame: Baseline, 2 weeks ]
    Change in function of intrinsically photosensitive retinal ganglion cells as quantified by the relative change in pupillary light response to blue light.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS
  • Evidence of sleep disturbance
  • Stable on immunomodulatory MS therapy or no therapy for at least 6 months prior to study initiation
  • Stable on antidepressants for at least 3 months prior to study initiation and no evidence
  • Stable on fatigue medication for at least 3 months prior to study initiation
  • Willing and able to provide informed consent and follow study procedures.

Exclusion Criteria:

  • Evidence of cognitive impairment
  • Low risk for sleep disordered breathing
  • Other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness)
  • Traveled across two time zones within 90 days of study screening.
  • Not participating in shift work
  • MS relapse or history of acute optic neuritis within 30 days
  • No prior history of bipolar disorder
  • No evidence of current depression
  • Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054050


Contacts
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Contact: Kathryn C Fitzgerald, ScD 443-287-6739 fitzgerald@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Kathryn C Fitzgerald, ScD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04054050    
Other Study ID Numbers: IRB00222887
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to other researchers. Since the study will enroll only 24 individuals, even if stripped of identifiers, it may still be possible to identify participants. Thus, data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
sleep disturbance
insomnia
fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Dyssomnias
Sleep Wake Disorders
Parasomnias
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms