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Completed

NCT Number: NCT01604876

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinson Disease Parkinsonian Disorders Sleep Wake Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center

Amsterdam, North Holland, 1118, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease
  • depression

Exclusion criteria

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

Treatment and study plan

light therapy 30 min morning and evening, three months

Device

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

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. 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

    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).

  2. Motor function

    Time frame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0

    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).

  3. 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

    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).

  4. 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

    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).

  5. 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

    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).

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • GGZ inGeest
  • International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands
  • Netherlands Brain Foundation
  • Netherlands Institute for Neurosciences, Amsterdam, The Netherlands
  • Parkinsonvereniging, Bunnik, the Netherlands

Registry information

Acronym: LightPD

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 24, 2012
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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