Effect of Bright Light on Mood and Sleep in Parkinson's Disease (LightPD)
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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 |
- 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).
- 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 |
Inclusion Criteria:
- Parkinson's disease
- depression
Exclusion Criteria:
- psychosis
- mania
- suicidality
- retinopathy
- previous light treatment
- use of photosensitising medication
Contacts and Locations| Contact: Odile A van den Heuvel, MD PHD | +31-20-4449615 | oa.vandenheuvel@vumc.nl |
| Netherlands | |
| VU University Medical Center | Recruiting |
| Amsterdam, North-Holland, Netherlands, 1118 | |
| Principal Investigator: Odile A van den Heuvel, MD PHD | |
| 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 May 23, 2013