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

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Description

This is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with Parkinson's disease

Targeted Conditions

Study Overview

Start Date
December 9, 2022
Completion Date
September 30, 2025
Enrollment
69
Date Posted
September 1, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
The Chinese University of Hong Kong
Hong Kong, Hong Kong

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Idiopathic Parkinson's disease diagnosed by neurologist according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria
Capable to give informed consent
Maintained on stable dose of medications for Parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study
Score 14 or more on the Epworth Sleepiness Scale

Exclusion Criteria:

A current or past history of manic or hypomanic episode, schizophrenia, mental retardation, or substance use disorder. (Subjects with depression or anxiety disorders will not be excluded)
Unstable medical or psychiatric condition
Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
Contraindication to bright light therapy: history of light induced migraine. Epilepsy, current use of photosensitizing medications, presence of eye disease, e.g. retinal disease, severe cataract, glaucoma and blindness
Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
Regular shift worker or trans-meridian flight in the past three months
Enrolment in another clinical trial of an investigational medicinal product or device
Subjects who are on exogenous melatonin
Patients with deep brain stimulation (DBS) implant
Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome

Study Contact Info

Study Contact Name
Joey WY Chan
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The primary aim of this study is to compare the efficacy of timed-BLT (BLT group) in reducing excessive daytime sleepiness in patients with Parkinson's disease, when compared to a timed-inactivated negative ion generator (active-control group).

The secondary aims of the study are to examine the effect of timed-BLT on other non-motor symptoms, including depression, fatigue; and the quality of life.

Additional analyses will be carried out to examine the efficacy of the timed-placebo as compared to the random-time placebo (placebo group).
NCTid (if applicable)
NCT05524961