Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence - Full Text View

Purpose

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.

Condition	Intervention
Parkinson's Disease Daytime Somnolence	Device: Bright Light Treatment (Sun Ray Sunbox SB-558) Device: Dim red light (Sun Ray Sunbox SB-558)

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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Change in the ESS comparing the bright light exposure with dim-red light exposure. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
ESS will be taken and compared at screening, week 4 and week 6 visits.

Secondary Outcome Measures:

The global PSQI score and PDSS score will be compared. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.
Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity level (a measurement of daytime function) will be collected. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Actigraphy measures will be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.
MSLT and polysomnograph (PSG) testing will be compared. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bright White Bright white light treatment group.	Device: Bright Light Treatment (Sun Ray Sunbox SB-558) Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day. Other Name: Sun Ray Sunbox SB-558
Placebo Comparator: Dim red light Dim red light control group.	Device: Dim red light (Sun Ray Sunbox SB-558) Dim red light box administered during two 1 hour periods during the day using Other Name: Sun Ray Sunbox SB-558

Detailed Description:

See above.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338649

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

National Parkinson Foundation

Investigators

Principal Investigator:

Aleksandar Videnovic, MD, MS

Northwestern University

More Information

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Responsible Party:	Aleksandar Videnovic, Assistant Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier:	NCT01338649 History of Changes
Other Study ID Numbers:	Light Therapy in PD
Study First Received:	April 18, 2011
Last Updated:	June 29, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Parkinson's disease
Daytime somnolence
Sleepiness
Light therapy

Additional relevant MeSH terms:

Parkinson Disease
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 19, 2013