Parkinson DiseaseNCT05524961
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
A study testing Bright light therapy and Inactivated negative ion generator in people with Parkinson Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Bright light therapy and Inactivated negative ion generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Dec 2022to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- Bright light therapy, Inactivated negative ion generator
- Keywords
- Parkinson disease, Light therapy, Daytime sleepiness, Non-motor symptom
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapyDevice
Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks
Inactivated negative ion generatorDevice
Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
Inactivated negative ion generatorDevice
Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Timed-Bright light therapy (BLT group) | Experimental | 10,000lux bright light Receives: Device: Bright light therapy |
| Timed-inactivated negative ion generator (Active-control group) | Active comparator | Inactivated negative ion generator Receives: Device: Inactivated negative ion generator |
| Random-time inactivated negative ion generator (placebo group) | Placebo comparator | Inactivated negative ion generator Receives: Device: Inactivated negative ion generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of daytime sleepiness
Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness
Measured: at the end of 6-week treatment
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: at the end of 6-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start9 Dec 2022
- Primary completion3 Oct 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo- and active-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joey WY Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524961
- Sponsor's protocol ID
- 2021.676T
- Status last verified
- Mar 2026
- First submitted
- 25 Aug 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05524961
- Acronym / sponsor ID
- 2021.676T
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Light therapy, Daytime sleepiness, Non-motor symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized placebo- and active-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Timed-Bright light therapy (BLT group) | Experimental | Device: Bright light therapy10,000lux bright light |
| Timed-inactivated negative ion generator (Active-control group) | Active comparator | Device: Inactivated negative ion generatorInactivated negative ion generator |
| Random-time inactivated negative ion generator (placebo group) | Placebo comparator | Device: Inactivated negative ion generatorInactivated negative ion generator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright light therapyRegularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks | Device | Timed-Bright light therapy (BLT group) |
| Inactivated negative ion generatorRegularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks | Device | Timed-inactivated negative ion generator (Active-control group) |
| Inactivated negative ion generatorRandomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks | Device | Random-time inactivated negative ion generator (placebo group) |
Primary outcome
Change of daytime sleepiness
Time frame: at the end of 6-week treatment
Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness
3 secondary outcomes
Change of depressive symptoms
Time frame: at the end of 6-week treatment
Change in fatigue symptoms
Time frame: at the end of 6-week treatment
Change in quality of life
Time frame: at the end of 6-week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light therapy and Inactivated negative ion generator in people with Parkinson Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of daytime sleepiness (time frame: at the end of 6-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.