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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timed-Bright light therapy (BLT group) | Experimental | 10,000lux bright light |
|
| Timed-inactivated negative ion generator (Active-control group) | Active Comparator | Inactivated negative ion generator |
|
| Random-time inactivated negative ion generator (placebo group) | Placebo Comparator | Inactivated negative ion generator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light therapy | Device | Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of depressive symptoms | Change in the score of Montgomery-Ã…sberg 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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Randomized placebo- and active-controlled trial
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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.
| Inactivated negative ion generator | Device | Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks |
|
| Inactivated negative ion generator | Device | Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks |
|
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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |