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

NCT ID: NCT05524961

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-09

Study Completion Date

2025-09-30

Brief Summary

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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

Detailed Description

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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).

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo- and active-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Timed-Bright light therapy (BLT group)

10,000lux bright light

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type DEVICE

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

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

Inactivated negative ion generator

Group Type ACTIVE_COMPARATOR

Inactivated negative ion generator

Intervention Type DEVICE

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

Random-time inactivated negative ion generator (placebo group)

Inactivated negative ion generator

Group Type PLACEBO_COMPARATOR

Inactivated negative ion generator

Intervention Type DEVICE

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

Interventions

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Bright light therapy

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

Intervention Type DEVICE

Inactivated negative ion generator

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

Intervention Type DEVICE

Inactivated negative ion generator

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Joey WY Chan

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Joey WY Chan

Role: CONTACT

+852 39197647

Facility Contacts

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Joey WY Chan, FHKAM(Psych)

Role: primary

+862 39197647

Jessie Tsang

Role: backup

+852 39197792

Other Identifiers

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2021.676T

Identifier Type: -

Identifier Source: org_study_id

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