Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease

Mass General Brigham

Status: Active, not recruiting

Conditions: Parkinson's Disease

Treatments: Device: Light Therapy Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02909192

2016P001775

Details and patient eligibility

About

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Enrollment: 65 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria
2. PD Hoehn and Yahr stage 2-4
3. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
4. Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed
5. Stable dose of PD medications for at least 4 weeks prior to the study screening.

Exclusion criteria

1. Atypical or secondary forms of parkinsonism
2. Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
3. Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS
4. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26
5. Presence of depression defined as the Beck Depression Inventory (BDI) score >14
6. Untreated hallucinations or psychosis (drug-induced or spontaneous)
7. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed
8. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening
9. Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists
10. Shift work, currently or within the prior 3 months
11. Travel through ≥ 2 time zones within 60 days prior to study screening
12. Hematocrit <32 mm3
13. Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
14. Dense cataracts
15. Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
16. Unstable/serious medical illness.
17. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Bright light therapy

Active Comparator group

Description:

Participants will be treated twice daily with bright light therapy.

Treatment:

Device: Light Therapy Device

Dim-Red light therapy

Active Comparator group

Description:

Participants will be treated twice daily with dim-red light therapy.

Treatment:

Device: Light Therapy Device