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

Primary Purpose

Parkinson's Disease, Sleep Disorder; Excessive Somnolence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bright Light Treatment (Sun Ray Sunbox SB-558)

Dim red light (Sun Ray Sunbox SB-558)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Daytime somnolence, Sleepiness, Light therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bright White

Dim red light

Arm Description

Exposure to bright white light treatment.

Exposure to dim red light treatment.

Outcomes

Primary Outcome Measures

Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.

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

Full Information

NCT ID

NCT01338649

First Posted

April 18, 2011

Last Updated

February 4, 2023

Sponsor

Northwestern University

Collaborators

National Parkinson Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01338649

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Parkinson Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Sleep Disorder; Excessive Somnolence

Keywords

Parkinson's disease, Daytime somnolence, Sleepiness, Light therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bright White

Arm Type

Active Comparator

Arm Description

Exposure to bright white light treatment.

Arm Title

Dim red light

Arm Type

Placebo Comparator

Arm Description

Exposure to dim red light treatment.

Intervention Type

Device

Intervention Name(s)

Bright Light Treatment (Sun Ray Sunbox SB-558)

Other Intervention Name(s)

Sun Ray Sunbox SB-558

Intervention Description

Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.

Intervention Type

Device

Intervention Name(s)

Dim red light (Sun Ray Sunbox SB-558)

Other Intervention Name(s)

Sun Ray Sunbox SB-558

Intervention Description

Dim red light box administered during two 1 hour periods during the day using

Primary Outcome Measure Information:

Title

Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.

Description

Time Frame

baseline and 4 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria Hoehn and Yahr stage of 2 to 4 in the "on" state Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points Stable PD medication regimen for at least 4 weeks prior to study screening Willing and able to give written informed consent Exclusion Criteria: Atypical parkinsonian syndromes Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG) 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) Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24 Presence of depression defined as the Beck Depression Inventory (BDI) score >14 Untreated hallucinations or psychosis (drug-induced or spontaneous) Use of hypno-sedative drugs for sleep or stimulants during the daytime Use of antidepressants unless the patient has been on a stable dose for at least three months Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness Travel through 2 time zones within 90 days prior to study screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aleksandar Videnovic, MD, MS

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

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

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