Parkinson's Disease, Sleep Disorder; Excessive Somnolence
Conditions
Keywords
Parkinson's disease, Daytime somnolence, Sleepiness, Light therapy
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.
Interventions
DEVICEBright 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.
DEVICEDim red light (Sun Ray Sunbox SB-558)
Dim red light box administered during two 1 hour periods during the day using
Sponsors
National Parkinson Foundation
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bright White Bright white light treatment group.
Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day. | 13 |
| Dim Red Light Dim red light control group.
Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Bright White | Dim Red Light | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 6.9 | 59.3 years STANDARD_DEVIATION 11.3 | 63.6 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 13 | 1 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
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.
Time frame: baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright White | Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | 4.46 score | Standard Deviation 2.54 |
| Dim Red Light | Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | 1.77 score | Standard Deviation 3 |
p-value: 0.0211t-test, 2 sided