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

NCT01604876 | Completed

• 1 other identifier: NL3905802912
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Depression

Keywords

Parkinson's disease; depression; light therapy; sleeping problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Motor function

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

• Quality of Life of patient

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

• 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

• Quality of life of caregiver

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

Study Arms (2)

light condition 1 + day night structure

EXPERIMENTAL

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 condition 2 + day night structure

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: light condition 1

light condition 1 + day night structure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease
• depression

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands: collaborator
• Parkinsonvereniging, Bunnik, the Netherlands: collaborator
• Netherlands Brain Foundation: collaborator
• Netherlands Institute for Neurosciences, Amsterdam, The Netherlands: collaborator
• GGZ inGeest: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1118, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30770426 DERIVED

• 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.

  PMID: 27769202 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Depression; Parasomnias

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Odile A van den Heuvel, MD PHD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Ysbrand D van der Werf, PHD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Jan H Smit, PHD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 24, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

NL (1)