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

Parkinson's Disease Clinical Trial

Official title:

Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909192
• Other study ID #: 2016P001775
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: Aleksandar Videnovic, MD, MSc
• Phone: 617-724-3837
• Email: avidenovic[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Light Therapy Device

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality		8 weeks
Secondary	Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness		8 weeks
Secondary	Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms		8 weeks
Secondary	Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation		8 weeks