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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Northwestern University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by (Responsible Party):
Aleksandar Videnovic, Northwestern University
ClinicalTrials.gov Identifier:
NCT01338649
First received: April 18, 2011
Last updated: June 29, 2012
Last verified: June 2012
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Stocchi F, Barbato L, Nordera G et al.: Sleep disorders in Parkinson's disease. J Neurol 245 Suppl 1S15-18 (1998).
Reid KJBurgess HJ: Circadian rhythm sleep disorders. Prim Care 32(2), 449-473 (2005).

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 August 27, 2014