Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence

Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability.

Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disorders of Excessive Somnolence Dyssomnias Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder; Excessive Somnolence Sleep Disorders, Intrinsic Sleep Wake Disorders Sleepiness Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria
Hoehn and Yahr stage of 2 to 4 in the "on" state
Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points
Stable PD medication regimen for at least 4 weeks prior to study screening
Willing and able to give written informed consent

Exclusion criteria

Atypical parkinsonian syndromes
Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)
Significant periodic limb movement disorder (defined as a PLM arousal index>10 events/hr of sleep on screening PSG) and REM sleep behavior disorder (based on the presence of both clinical symptomatology as well as intermittent loss of REM atonia on screening PSG)
Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
Presence of depression defined as the Beck Depression Inventory (BDI) score >14
Untreated hallucinations or psychosis (drug-induced or spontaneous)
Use of hypno-sedative drugs for sleep or stimulants during the daytime
Use of antidepressants unless the patient has been on a stable dose for at least three months
Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness
Travel through 2 time zones within 90 days prior to study screening

Treatment and study plan

Bright Light Treatment (Sun Ray Sunbox SB-558)

Device

Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.

Other names: Sun Ray Sunbox SB-558

Dim red light (Sun Ray Sunbox SB-558)

Device

Dim red light box administered during two 1 hour periods during the day using

Other names: Sun Ray Sunbox SB-558

Primary outcomes

Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.

Time frame: baseline and 4 weeks

ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Parkinson Foundation

Registry information

Official study title

Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Apr 19, 2011
Registry last updated: Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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