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

Trial ID: NCT05524961

Interventional - Phase Unknown - Completed

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

Conditions

• Parkinson Disease

Interventions

• Bright light therapy
• Inactivated negative ion generator
• Inactivated negative ion generator

Eligibility

Inclusion criteria

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

Exclusion criteria

• 1. 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)
• 2. Unstable medical or psychiatric condition
• 3. Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
• 4. Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
• 5. Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
• 6. 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
• 7. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
• 8. Regular shift worker or trans-meridian flight in the past three months
• 9. Enrolment in another clinical trial of an investigational medicinal product or device
• 10. Subjects who are on exogenous melatonin
• 11. Patients with deep brain stimulation (DBS) implant
• 12. Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome

Sponsor

Chinese University of Hong Kong

Source: ClinicalTrials.gov

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