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

Study Overview
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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).

Official Title
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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
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Parkinson Disease

Intervention / Treatment
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* Device: Bright light therapy
* Device: Inactivated negative ion generator
* Device: Inactivated negative ion generator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo- and active-controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Light therapy, Daytime sleepiness, Non-motor symptom