Light Therapy in Parkinson's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Bright light box: The 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: The 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)
  Total sleep time is the sum of sleep time in each period. This outcome reflects change of patients' sleep quality.
• 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)
  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.
• 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)
  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.
• Change from baseline in sleep onset latency polysomnography (PSG) at the end of each intervention period — visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
  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.
• Change from baseline in Periodic Limb Movement during Sleep(PLMS) by polysomnography (PSG) at the end of each intervention period — visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
  Periodic limb movement during sleep (PLMS) is is described as a stereotypical involuntary movement during sleep. In particular, presenting more than 15 periodic limb movements per hour is related to daytime sleepiness due to low sleep quality. This outcome reflects change of patients' sleep quality.
• Changes from baseline in duration and percentage of each sleep stage by polysomnography (PSG) at the end of each intervention period — visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
  Changes in the length and percentage of N1, N2, N3 and REM sleep,which reflect changes in sleep structure.
• Changes from baseline in slow wave activity(SWA) and slow wave energy(SWE) by polysomnography (PSG) at the end of each intervention period — visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
  SWA and SWE are indicators of sleep depth and homeostasis in PSG.

Trial sites (1)

More Second Affiliated Hospital of Soochow University trials in China

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