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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Parkinson's Disease
• Intervention / Treatment: Device: light therapy 30 min morning and evening, three months; Device: light therapy 30 min morning and evening, three months

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North-Holland
    • Amsterdam, North-Holland, Netherlands, 1118
      • VU University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parkinson's disease
• depression

Exclusion Criteria:

• psychosis
• mania
• suicidality
• retinopathy
• previous light treatment
• use of photosensitising medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: light condition 1 + day night structure; exposure to 10.000 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.	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.; Other Names: light condition 1; Device: 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.; Other Names: light condition 2
Active Comparator: light condition 2 + day night structure; exposure to 200 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.	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.; Other Names: light condition 1; Device: 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.; Other Names: light condition 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Netherlands Brain Foundation; GGZ inGeest; International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands; Parkinsonvereniging, Bunnik, the Netherlands; Netherlands Institute for Neurosciences, Amsterdam, The Netherlands
• Investigators: Principal Investigator: Odile A van den Heuvel, MD PHD, Amsterdam UMC, location VUmc; Principal Investigator: Ysbrand D van der Werf, PHD, Amsterdam UMC, location VUmc; Study Director: Jan H Smit, PHD, Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• Rutten S, Vriend C, Smit JH, Berendse HW, van Someren EJW, Hoogendoorn AW, Twisk JWR, van der Werf YD, van den Heuvel OA. Bright light therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2019 Mar 12;92(11):e1145-e1156. doi: 10.1212/WNL.0000000000007090. Epub 2019 Feb 15.
• Rutten S, Vriend C, Smit JH, Berendse HW, Hoogendoorn AW, van den Heuvel OA, van der Werf YD. A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease. BMC Psychiatry. 2016 Oct 21;16(1):355. doi: 10.1186/s12888-016-1050-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 24, 2012

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: depression; Parkinson's disease; light therapy; sleeping problems
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Parkinson Disease
• Other Study ID Numbers: NL3905802912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data may be shared on reasonable request