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

Not Applicable

Completed

• Conditions: Depression; Parkinson's Disease
• Interventions: Device: light therapy 30 min morning and evening, three months

• Registration Number: NCT01604876
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Parkinson's disease
• depression

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
light condition 1 + day night structure	light therapy 30 min morning and evening, three months	exposure to 10.000 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.
light condition 2 + day night structure	light therapy 30 min morning and evening, three months	exposure to 200 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.

Primary Outcome Measures

Name	Time	Method
Mood	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 Outcome Measures

Name	Time	Method
Sleep	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).
Motor function	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).
Quality of Life of patient	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).
Circadian rhythm	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).
Quality of life of caregiver	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).

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, North-Holland, Netherlands