Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
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.
Interventions
DEVICELight Therapy Device
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness | 8 weeks |
| Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms | 8 weeks |
| Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation | 8 weeks |
Countries
United States
Outcome results
None listed