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

This study has been completed.
National Parkinson Foundation
Information provided by (Responsible Party):
Aleksandar Videnovic, Northwestern University Identifier:
First received: April 18, 2011
Last updated: September 3, 2014
Last verified: September 2014

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
Sleep Disorder; Excessive 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • The Global PSQI Score and PDSS Score Will be Compared. [ Time Frame: 6 weeks ]
    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 ]
    Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill 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 ]
    MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.

Enrollment: 27
Study Start Date: November 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bright White
Exposure to bright white light treatment.
Device: Bright Light Treatment (Sun Ray Sunbox SB-558)
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 Name: Sun Ray Sunbox SB-558
Placebo Comparator: Dim red light
Exposure to dim red light treatment.
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Atypical parkinsonian syndromes
  2. Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)
  3. 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)
  4. Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
  5. Presence of depression defined as the Beck Depression Inventory (BDI) score >14
  6. Untreated hallucinations or psychosis (drug-induced or spontaneous)
  7. Use of hypno-sedative drugs for sleep or stimulants during the daytime
  8. Use of antidepressants unless the patient has been on a stable dose for at least three months
  9. Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness
  10. Travel through 2 time zones within 90 days prior to study screening
  Contacts and Locations
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Please refer to this study by its identifier: NCT01338649

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Parkinson Foundation
Principal Investigator: Aleksandar Videnovic, MD, MS Northwestern University
  More Information


Responsible Party: Aleksandar Videnovic, Assistant Professor of Neurology, Northwestern University Identifier: NCT01338649     History of Changes
Other Study ID Numbers: Light Therapy in PD
Study First Received: April 18, 2011
Results First Received: July 22, 2014
Last Updated: September 3, 2014

Keywords provided by Northwestern University:
Parkinson's disease
Daytime somnolence
Light therapy

Additional relevant MeSH terms:
Parkinson Disease
Sleep Wake Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders processed this record on April 28, 2017