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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524961
• Other study ID #: 2021.676T
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Joey WY Chan
• Phone: +852 39197647
• Email: joeywychan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Bright light therapy
Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks
• Inactivated negative ion generator
Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks
• Inactivated negative ion generator
Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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