Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light Therapy Device
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
Eligibility Criteria
Inclusion criteria:
- Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria
- PD Hoehn and Yahr stage 2-4
- Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
- Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed
- Stable dose of PD medications for at least 4 weeks prior to the study screening.
Exclusion criteria:
- Atypical or secondary forms of parkinsonism
- Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
- Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS
- Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26
- Presence of depression defined as the Beck Depression Inventory (BDI) score >14
- Untreated hallucinations or psychosis (drug-induced or spontaneous)
- 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
- 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
- Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists
- Shift work, currently or within the prior 3 months
- Travel through ≥ 2 time zones within 60 days prior to study screening
- Hematocrit <32 mm3
- Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
- Dense cataracts
- Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
- Unstable/serious medical illness.
- Pregnancy
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bright light therapy
Dim-Red light therapy
Arm Description
Participants will be treated twice daily with bright light therapy.
Participants will be treated twice daily with dim-red light therapy.
Outcomes
Primary Outcome Measures
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality
Secondary Outcome Measures
Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness
Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms
Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation
Full Information
NCT ID
NCT02909192
First Posted
September 15, 2016
Last Updated
November 24, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02909192
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bright light therapy
Arm Type
Active Comparator
Arm Description
Participants will be treated twice daily with bright light therapy.
Arm Title
Dim-Red light therapy
Arm Type
Active Comparator
Arm Description
Participants will be treated twice daily with dim-red light therapy.
Intervention Type
Device
Intervention Name(s)
Light Therapy Device
Primary Outcome Measure Information:
Title
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness
Time Frame
8 weeks
Title
Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms
Time Frame
8 weeks
Title
Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria
PD Hoehn and Yahr stage 2-4
Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed
Stable dose of PD medications for at least 4 weeks prior to the study screening.
Exclusion criteria:
Atypical or secondary forms of parkinsonism
Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS
Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26
Presence of depression defined as the Beck Depression Inventory (BDI) score >14
Untreated hallucinations or psychosis (drug-induced or spontaneous)
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
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
Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists
Shift work, currently or within the prior 3 months
Travel through ≥ 2 time zones within 60 days prior to study screening
Hematocrit <32 mm3
Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
Dense cataracts
Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
Unstable/serious medical illness.
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandar Videnovic, MD, MSc
Phone
617-724-3837
Email
avidenovic@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar Videnovic, MD, MSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Stauder, B.S.
Phone
617-726-9589
Email
mstauder@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
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