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Light Therapy in Parkinson's Disease
NCT06129942 · Second Affiliated Hospital of Soochow University
In plain English
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Official title
Light Therapy in Parkinson's Disease: a Prospective, Observational Study
About this study
As the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. At present, it is gradually used in sleep and neuropsychiatric diseases. In an open study, 120 patients with PD received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. The patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. Clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of PD patients. It was found that strong light can significantly improve the patients' motor and non-motor symptoms. However, these findings have not been reported in Chinese PD patients. The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease and explore the possible mechanism.
Eligibility criteria
Inclusion Criteria:
* According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-3.
* All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.
Exclusion Criteria:
* Using hypnotic or stimulating drugs.
* Using antidepressants, except stable drugs maintained for more than three months;
* Visual impairment, such as cataract, glaucoma, blindness, etc;
* Cognitive impairment (MMSE \< 24);
* There are uncontrollable hallucinations and mental diseases;
* There are sleep phase delay / advance syndrome, shift work, jet lag, etc
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2021-09-01
Estimated completion: 2026-05-16
Last updated: 2025-02-12
Interventions
Device: Bright light boxDevice: Dim Light box
Primary outcomes
- • Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period (visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- • Changes from baseline in sleep efficient by polysomnography (PSG) at the end of each intervention period (visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- • Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at the end of each intervention period (visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
Sponsor
Second Affiliated Hospital of Soochow University · other
Contacts & investigators
ContactChun-Feng Liu, PhD · contact · liuchunfeng@suda.edu.cn · +86 512 67783307
InvestigatorChun-Feng Liu, PhD · principal_investigator, Second Affiliated Hospital of Soochow University
All locations (1)
Department of Neurology, Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China