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

February 4, 2023 updated by: Aleksandar Videnovic, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sun Ray Sunbox SB-558

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Parkinson Foundation

Investigators

  • Principal Investigator: Aleksandar Videnovic, MD, MS, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Light Therapy in PD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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