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

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

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

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Bright light therapy; Device: Inactivated negative ion generator; Device: Inactivated negative ion generator

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).

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joey WY Chan; Phone Number: +852 39197647; Email: joeywychan@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Joey WY Chan, FHKAM(Psych); Phone Number: +862 39197647; Email: joeywychan@cuhk.edu.hk
    • Contact: Jessie Tsang; Phone Number: +852 39197792; Email: jessietsang@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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)
2. Unstable medical or psychiatric condition
3. Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
4. Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
5. Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
6. 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
7. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
8. Regular shift worker or trans-meridian flight in the past three months
9. Enrolment in another clinical trial of an investigational medicinal product or device
10. Subjects who are on exogenous melatonin
11. Patients with deep brain stimulation (DBS) implant
12. Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Timed-Bright light therapy (BLT group); 10,000lux bright light	Device: Bright light therapy; Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks
Active Comparator: Timed-inactivated negative ion generator (Active-control group); Inactivated negative ion generator	Device: Inactivated negative ion generator; Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks; Device: Inactivated negative ion generator; Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
Placebo Comparator: Random-time inactivated negative ion generator (placebo group); Inactivated negative ion generator	Device: Inactivated negative ion generator; Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks; Device: Inactivated negative ion generator; Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of daytime sleepiness	Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness	at the end of 6-week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of depressive symptoms	Change in the score of Montgomery-Åsberg Depression Rating Scale (MADRS), MARDS ranges from 0-60, higher score indicates greater severity of depressive symptoms	at the end of 6-week treatment
Change in fatigue symptoms	Change in the score of Faitgue Severity Scale (FSS), FSS consists of 9 items and each as rated on a scale from 1-7, higher score indicates greater severity of fatigue	at the end of 6-week treatment
Change in quality of life	Change in score of Short-Form 12-item (SF-12) scale. SF-12 consists of two subscales - a mental component score (MCS-12) and a physical component score (PCS-12), a higher score indicates better quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning	at the end of 6-week treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson disease; Light therapy; Daytime sleepiness; Non-motor symptom
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2021.676T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No