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

NCT ID: NCT01604876

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2017-02-28

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.

Conditions

Parkinson's Disease; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

light condition 1 + day night structure

exposure to 10.000 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.

Group Type: EXPERIMENTAL

light therapy 30 min morning and evening, three months

Intervention Type: 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.

light condition 2 + day night structure

exposure to 200 lux light twice daily (morning + evening) for 30 minutes during 3 months at home.

Group Type: ACTIVE_COMPARATOR

light therapy 30 min morning and evening, three months

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

light condition 1; light condition 2

Eligibility Criteria

Inclusion Criteria

• Parkinson's disease
• depression

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Parkinsonvereniging, Bunnik, the Netherlands

UNKNOWN

Sponsor Role: collaborator

Netherlands Brain Foundation

OTHER

Sponsor Role: collaborator

Netherlands Institute for Neurosciences, Amsterdam, The Netherlands

UNKNOWN

Sponsor Role: collaborator

GGZ inGeest

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

O.A. van den Heuvel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Odile A van den Heuvel, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Ysbrand D van der Werf, PHD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Jan H Smit, PHD

Role: STUDY_DIRECTOR

Amsterdam UMC, location VUmc

Locations

VU University Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 30770426 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27769202 (View on PubMed)

Other Identifiers

NL3905802912

Identifier Type: -

Identifier Source: org_study_id