Bright Light Therapy for Non-motor Symptoms in Parkinson'... | NCT02909192

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

NCT02909192

Sponsor

Massachusetts General Hospital

Status

Active, not recruiting

Last Update Posted

Nov 5, 2025Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

Light Therapy Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jul 5, 2022Actual

Completion Date

Nov 2026Estimated

First Submitted Date

Sep 15, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2025

Last Update Posted Date

Nov 5, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bright light therapy	Active Comparator	Participants will be treated twice daily with bright light therapy.	Device: Light Therapy Device
Dim-Red light therapy	Active Comparator	Participants will be treated twice daily with dim-red light therapy.	Device: Light Therapy Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Light Therapy Device	Device		Bright light therapy Dim-Red light therapy

Measure	Description	Time Frame
Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality		8 weeks

Measure	Description	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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010300	Parkinson Disease
D006970	Disorders of Excessive Somnolence

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases