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

NCT01338649 | Completed Results DMC

• 1 other identifier: Light Therapy in PD
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Sleep Disorder; Excessive Somnolence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 4 weeks

Study Arms (2)

Bright White

ACTIVE COMPARATOR

Exposure to bright white light treatment.

Device: Bright Light Treatment (Sun Ray Sunbox SB-558)

Dim red light

PLACEBO COMPARATOR

Exposure to dim red light treatment.

Device: Dim red light (Sun Ray Sunbox SB-558)

Interventions

Bright Light Treatment (Sun Ray Sunbox SB-558) 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.

Also known as: Sun Ray Sunbox SB-558

Bright White

Dim red light (Sun Ray Sunbox SB-558) DEVICE

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

Also known as: Sun Ray Sunbox SB-558

Dim red light

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Parkinson Foundation: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Parkinson Disease; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Results Point of Contact

• Title: Aleksandar Videnovic
• Organization: Massachusetts General Hospital

avidenovic@mgh.harvard.edu

855-644-6387

Study Officials

• Aleksandar Videnovic, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 19, 2011
• Study Start: November 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 1, 2023
• Results First Posted: September 5, 2014

Record last verified: 2023-02

Locations

US (1)