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

NCT05524961 | Completed

• 1 other identifier: 2021.676T
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson disease; Light therapy; Daytime sleepiness; Non-motor symptom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of depressive symptoms

  at the end of 6-week treatment

• Change in fatigue symptoms

  at the end of 6-week treatment

• Change in quality of life

  at the end of 6-week treatment

Study Arms (3)

Timed-Bright light therapy (BLT group)

EXPERIMENTAL

10,000lux bright light

Device: Bright light therapy

Timed-inactivated negative ion generator (Active-control group)

ACTIVE COMPARATOR

Inactivated negative ion generator

Device: Inactivated negative ion generator

Random-time inactivated negative ion generator (placebo group)

PLACEBO COMPARATOR

Inactivated negative ion generator

Device: Inactivated negative ion generator

Interventions

Bright light therapy DEVICE

Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks

Timed-Bright light therapy (BLT group)

Inactivated negative ion generator DEVICE

Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks

Timed-inactivated negative ion generator (Active-control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Parkinson Disease; Disorders of Excessive Somnolence

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and the negative ion generator, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Randomized placebo- and active-controlled trial

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 1, 2022
• Study Start: December 9, 2022
• Primary Completion: October 3, 2025
• Study Completion: January 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)