Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
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: September 3, 2014
Last verified: September 2014
  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
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
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 Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ 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 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 ] [ 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.


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.

  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
Results First Received: July 22, 2014
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Parasomnias
Parkinson Disease
Sleep Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014