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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by VU University Medical Center
Sponsor:
Collaborators:
International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands
Parkinsonvereniging, Bunnik, the Netherlands
Netherlands Brain Foundation
Netherlands Institute for Neurosciences, Amsterdam, The Netherlands
GGZ inGeest, Amsterdam, The Netherlands
Information provided by (Responsible Party):
O.A. van den Heuvel, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01604876
First received: May 17, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Parkinson's Disease
Depression
Device: light therapy 30 min morning and evening, three months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Bright Light on Mood and Sleep in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Motor function [ Time Frame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: light condition 1
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

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 Name: light condition 2

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease
  • depression

Exclusion Criteria:

  • psychosis
  • mania
  • suicidality
  • retinopathy
  • previous light treatment
  • use of photosensitising medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604876

Contacts
Contact: Odile A van den Heuvel, MD PHD +31-20-4449615 oa.vandenheuvel@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, North-Holland, Netherlands, 1118
Principal Investigator: Odile A van den Heuvel, MD PHD         
Sponsors and Collaborators
VU University Medical Center
International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands
Parkinsonvereniging, Bunnik, the Netherlands
Netherlands Brain Foundation
Netherlands Institute for Neurosciences, Amsterdam, The Netherlands
GGZ inGeest, Amsterdam, The Netherlands
Investigators
Principal Investigator: Odile A van den Heuvel, MD PHD VU University Medical Center
Principal Investigator: Ysbrand D van der Werf, PHD VU University Medical Center
Study Director: Jan H Smit, PHD VU University Medical Center
  More Information

No publications provided

Responsible Party: O.A. van den Heuvel, Principal Investigator, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01604876     History of Changes
Other Study ID Numbers: NL3905802912
Study First Received: May 17, 2012
Last Updated: May 23, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
Parkinson's disease
depression
light therapy
sleeping problems

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 19, 2014