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

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ClinicalTrials.gov Identifier: NCT01338649
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by (Responsible Party):
Aleksandar Videnovic, Northwestern University

Brief Summary:

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 or disease Intervention/treatment Phase
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) Not Applicable

Detailed Description:
See above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : November 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: April 19, 2011    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Aleksandar Videnovic, Northwestern University:
Parkinson's disease
Daytime somnolence
Sleepiness
Light therapy

Additional relevant MeSH terms:
Parkinson Disease
Sleep Wake Disorders
Parasomnias
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