RecruitingNot ApplicableNCT05524961

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

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


Sponsor

Chinese University of Hong Kong

Enrollment

69 participants

Start Date

Dec 9, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Idiopathic Parkinson's disease diagnosed by neurologist according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria
  • Capable to give informed consent
  • Maintained on stable dose of medications for Parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study
  • Score 14 or more on the Epworth Sleepiness Scale

Exclusion Criteria12

  • 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)
  • Unstable medical or psychiatric condition
  • Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
  • Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
  • Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
  • 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
  • Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
  • Regular shift worker or trans-meridian flight in the past three months
  • Enrolment in another clinical trial of an investigational medicinal product or device
  • Subjects who are on exogenous melatonin
  • Patients with deep brain stimulation (DBS) implant
  • Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome

Interventions

DEVICEBright light therapy

Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks

DEVICEInactivated negative ion generator

Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks

DEVICEInactivated negative ion generator

Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05524961


Related Trials