Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
NCT ID: NCT01338649
Last Updated: 2023-03-01
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
27 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-11-30
Study Completion Date
2012-10-31
Brief Summary
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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.
Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.
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Detailed Description
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See above.
Conditions
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Parkinson's Disease
Sleep Disorder; Excessive Somnolence
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Bright White
Exposure to bright white light treatment.
Group Type
ACTIVE_COMPARATOR
Bright Light Treatment (Sun Ray Sunbox SB-558)
Intervention Type
DEVICE
Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.
Dim red light
Exposure to dim red light treatment.
Group Type
PLACEBO_COMPARATOR
Dim red light (Sun Ray Sunbox SB-558)
Intervention Type
DEVICE
Dim red light box administered during two 1 hour periods during the day using
Interventions
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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.
Intervention Type
DEVICE
Dim red light (Sun Ray Sunbox SB-558)
Dim red light box administered during two 1 hour periods during the day using
Intervention Type
DEVICE
Other Intervention Names
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Sun Ray Sunbox SB-558
Sun Ray Sunbox SB-558
Eligibility Criteria
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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
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
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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Parkinson Foundation
OTHER
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
lead
Responsible Party
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Aleksandar Videnovic
Assistant Professor of Neurology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Aleksandar Videnovic, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192.
Reference Type
DERIVED
Other Identifiers
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Light Therapy in PD
Identifier Type: -
Identifier Source: org_study_id
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