Back to resultsBright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Bright light therapy
Inactivated negative ion generator
Inactivated negative ion generator
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Light therapy, Daytime sleepiness, Non-motor symptom
Eligibility Criteria
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
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Timed-Bright light therapy (BLT group)
Timed-inactivated negative ion generator (Active-control group)
Random-time inactivated negative ion generator (placebo group)
Arm Description
10,000lux bright light
Inactivated negative ion generator
Inactivated negative ion generator
Outcomes
Primary Outcome Measures
Change of daytime sleepiness
Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT05524961
First Posted
August 25, 2022
Last Updated
February 7, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05524961
Brief Title
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Light therapy, Daytime sleepiness, Non-motor symptom
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo- and active-controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Timed-Bright light therapy (BLT group)
Arm Type
Experimental
Arm Description
10,000lux bright light
Arm Title
Timed-inactivated negative ion generator (Active-control group)
Arm Type
Active Comparator
Arm Description
Inactivated negative ion generator
Arm Title
Random-time inactivated negative ion generator (placebo group)
Arm Type
Placebo Comparator
Arm Description
Inactivated negative ion generator
Intervention Type
Device
Intervention Name(s)
Bright light therapy
Intervention Description
Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks
Intervention Type
Device
Intervention Name(s)
Inactivated negative ion generator
Intervention Description
Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
Intervention Type
Device
Intervention Name(s)
Inactivated negative ion generator
Intervention Description
Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
Primary Outcome Measure Information:
Title
Change of daytime sleepiness
Description
Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness
Time Frame
at the end of 6-week treatment
Secondary Outcome Measure Information:
Title
Change of depressive symptoms
Description
Change in the score of Montgomery-Åsberg Depression Rating Scale (MADRS), MARDS ranges from 0-60, higher score indicates greater severity of depressive symptoms
Time Frame
at the end of 6-week treatment
Title
Change in fatigue symptoms
Description
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
Time Frame
at the end of 6-week treatment
Title
Change in quality of life
Description
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
Time Frame
at the end of 6-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joey WY Chan
Phone
+852 39197647
Email
joeywychan@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joey WY Chan, FHKAM(Psych)
Phone
+862 39197647
Email
joeywychan@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Jessie Tsang
Phone
+852 39197792
Email
jessietsang@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
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