Light Therapy in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorSecond Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Crossover
Treatments tested in this trial
Bright light box
DeviceThe light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The experimental group is treated with 10,000 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.
Dim Light box
DeviceThe light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The control group is treated with 300 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Dim light groupPlacebo comparator 1 intervention
Group B: Bright light groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period
Total sleep time is the sum of sleep time in each period. This outcome reflects change of patients' sleep quality.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)2
Changes from baseline in sleep efficient by polysomnography (PSG) at the end of each intervention period
Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed. This outcome reflects change of patients' sleep quality.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)3
Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at the end of each intervention period
REM sleep without atonia (RWA) is the PSG finding of persistent muscle tone during REM sleep, resulting in paroxysmal phasic or tonic EMG activity. Together with dream-enacting behavior (DEB), RSWA is a necessary diagnostic criterion of REM sleep behavior disorder (RBD). This outcome reflects change of RBD severity.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)4
Change from baseline in sleep onset latency polysomnography (PSG) at the end of each intervention period
Sleep latency is the amount of time it takes patients to go from being fully awake to sleeping. Patients' sleep latency and how quickly they reach rapid eye movement (REM) sleep can be indicators of the amount and quality of sleep they are getting.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)Secondary outcomes
1
Changes from baseline in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of each intervention period
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an effective tool to evaluate the severity of motor symptoms in patients with Parkinson's disease (PD).Each item is simply given a 5- point score: 0 (Absent) to 4 (Marked in amplitude and present most of the time).The higher the MDS-UPDRS score is, the worse the symptoms are.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)2
Changes form baseline in Hoehn-Yahr scale at the end of each intervention period
In H-Y scale, PD is divided into 5 stages according to the range and extent of motor symptoms. The higher the H-Y scale is, the worse the symptoms are.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)3
Changes form baseline in PDSS-2 score scale at the end of each intervention period
The Parkinson's Disease Sleep Scale-2(PDSS-2) assesses a wide spectrum of disease-specific sleep problems.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)4
Changes form baseline in Pittsburgh sleep quality index (PSQI) score at the end of each intervention period
The Pittsburgh sleep quality index (PSQI) is widely used to measure sleep quality. The best cut-off score was 7. The higher the PSQI score is, the worse the sleep quality is.
Time frame
visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)Sponsors and contacts
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Source ClinicalTrials.gov