Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

Johns Hopkins University

Status

Invitation-only

Conditions

Multiple Sclerosis

Treatments

Other: Light therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04054050

IRB00222887

R03HD101056 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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