Clinical trial NCT02909192: Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Official title: Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Excessive Daytime Sleepiness
Circadian Rhythms
Light Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality
timeFrame: 8 weeks
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness
timeFrame: 8 weeks
measure: Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms
timeFrame: 8 weeks
measure: Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aleksandar Videnovic, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: