Overview

This trial is active, not recruiting.

Conditions parkinson's disease, depression
Treatments light therapy 30 min morning and evening, three months
Sponsor VU University Medical Center
Collaborator International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands
Start date May 2012
End date February 2017
Trial size 83 participants
Trial identifier NCT01604876, NL3905802912

Summary

The purpose of this clinical trial is to investigate whether light therapy is a suitable treatment option for depression and insomnia in Parkinson's disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
exposure to 10.000 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.
light therapy 30 min morning and evening, three months light condition 1
Light from a commercially available table-mounted lightbox (Brazil, Lumie, Cambridge UK) [dimensions 50.2 x 32 x 15.4 cm] equipped with 3x36W Fluorescent bulbs (Osram 954), reflectors and a diffuser screen providing 10,000 lux at 30 cm eye level distance. therapy consists of 30 minutes light exposure in the morning and evening during 3 months.
(Active Comparator)
exposure to 200 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.
light therapy 30 min morning and evening, three months light condition 2
200 lux light from a commercially available table-mounted lightbox (Brazil, Lumie, Cambridge UK) [dimensions 50.2 x 32 x 15.4 cm] To lower the intensity to 200 lux the bulbs are enwrapped with one layer of L299s neutral density filter (LEE Filters, Andover, UK). Therapy consists of 30 minutes light exposure in the morning and evening during 3 months.

Primary Outcomes

Measure
Mood
time frame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0

Secondary Outcomes

Measure
Sleep
time frame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
Motor function
time frame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
Quality of Life of patient
time frame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
Circadian rhythm
time frame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
Quality of life of caregiver
time frame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Parkinson's disease - depression Exclusion Criteria: - psychosis - mania - suicidality - retinopathy - previous light treatment - use of photosensitising medication

Additional Information

Official title Effect of Bright Light on Mood and Sleep in Parkinson's Disease
Principal investigator Odile A van den Heuvel, MD PHD
Description The quality of life of patients with Parkinson's disease and their caretakers is mainly influenced by so called non-motor symptoms. This includes neuropsychiatric consequences of the disease like depression and sleeping problems. The incidence of depressed mood in patients with Parkinson is approximately 50%, the incidence for sleeping problems is 90%. These symptoms are often overlooked and even if recognized, inadequately treated. The treatment of mood and sleep disturbances in Parkinson patients is hampered by adverse effects, incomplete responses to the usual treatments and the absence of specific treatment options for these symptoms in Parkinson's disease. On the basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus in Parkinson's disease it is expected that stimulation of this nucleus by bright light therapy will result in improved functioning on multiple different domains: mood, sleep, motor functions, quality of life and circadian rhythms. Because there are virtually no side effects and the possibility of home treatment, light therapy is expected to be highly appreciated by the patients.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by VU University Medical Center.