Clinical trial NCT06129942: Light Therapy in Parkinson's Disease
Official title: Light Therapy in Parkinson's Disease: a Prospective, Observational Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Sleep Disorder
Circadian Rhythm Disorders
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in sleep efficient by polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Change from baseline in sleep onset latency polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Change from baseline in Periodic Limb Movement during Sleep(PLMS) by polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in duration and percentage of each sleep stage by polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in slow wave activity(SWA) and slow wave energy(SWE) by polysomnography (PSG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary outcomes:
measure: Changes from baseline in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes form baseline in Hoehn-Yahr scale at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes form baseline in PDSS-2 score scale at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes form baseline in Pittsburgh sleep quality index (PSQI) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Epworth sleepiness scale (ESS) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Morningness-Eveningness Questionnaire (MEQ) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Hamilton Anxiety Scale(HAMA) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes in Montreal Cognitive Assessment (MoCA) score at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Non-Motor Symptoms Questionnaire at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Parkinson's Disease Questionnaire (PDQ-39) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in Fatigue Severity Scale (FSS) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in electroencephalogram(EEG) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in the rhythmic level of melatonin in serum and saliva at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in the rhythmic level of cortisol in serum and saliva at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
measure: Changes from baseline in functional magnetic resonance(fMRI) at the end of each intervention period
timeFrame: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Department of Neurology, Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-Feng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
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