Effect of Bright Light on Mood and Sleep in Parkinson's Disease

Depression Clinical Trial

— LightPD  

Official title:

Effect of Bright Light on Mood and Sleep in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604876
• Other study ID #: NL3905802912
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: February 2017

Study information

• Verified date: December 2021
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parkinson's disease

• depression

Exclusion Criteria:

• psychosis

• mania

• suicidality

• retinopathy

• previous light treatment

• use of photosensitising medication

Related Conditions & MeSH terms

• Depression
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• light therapy 30 min morning and evening, three months
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.
• light therapy 30 min morning and evening, three months
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.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	North-Holland

Sponsors (6)

Lead Sponsor	Collaborator
VU University Medical Center	GGZ inGeest, International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands, Netherlands Brain Foundation, Netherlands Institute for Neurosciences, Amsterdam, The Netherlands, Parkinsonvereniging, Bunnik, the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood	using Hamilton Depression Rating Scale (HDRS - 17 items) and Geriatric Depression Scale-30 (GDS - 30 items) at baseline (T0), halfway therapy, six weeks (T1), end of therapy, three months (T2), at 1 month follow-up (T3), 3 months follow-up (T4) and 6 months follow-up (T5).; The direct treatment effect (= difference score between baseline and end of treatment),; The long-lasting treatment effect (= difference score between baseline and end of follow-up).; The dichotomous treatment response (> 50 % decrease score at T2), in order to calculate the Numbers Needed to Treat (NNT).	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	Sleep	using Scales for Outcomes in Parkinson's Disease-Sleep subscale (SCOPA-sleep - 14 items) assessed at baseline (T0), after 6 weeks of light therapy (T1), after 3 months of light therapy (end of treatment, T2), 1 month post-treatment (T3), 3 months post-treatment (T4) and 6 months post-treatment (T5).	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	Motor function	using Unified Parkinson's Disease Rating Scale-Section III motor score (UPDRS-III - 14 items) at 3 time points: at baseline (T0), after 3 months of light therapy (T2) and 6 months follow-up (T5).	T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
Secondary	Quality of Life of patient	using the World Health Organization Quality of Life Assessment Short Version (WHOQOL-BREF) assessed at 3 time points, at baseline (T0), after 3 months of light therapy (T2) and 6 months follow-up (T5).	T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
Secondary	Circadian rhythm	Circadian rhythm as measured by melatonin and cortisol day/night curves and actigraphy are assessed at 6 time points, at baseline (T0), after 6 weeks of light therapy (T1), after 3 months of light therapy (T2), 1 month follow-up (T3), 3 months follow-up (T4) and 6 months follow-up (T5).	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	Quality of life of caregiver	using the Zarit Burden Interview (ZBI - 22 items) for caregivers, assessed at 3 time points, at baseline (T0), after 3 months of light therapy (T2) and 6 months follow-up (T5).	T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0