Trial Outcomes & Findings for Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence (NCT NCT01338649)
NCT ID: NCT01338649
Last Updated: 2023-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
Baseline characteristics by cohort
| Measure |
Bright White
n=13 Participants
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.
|
Dim Red Light
n=14 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksESS 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.
Outcome measures
| Measure |
Bright White
n=13 Participants
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.
|
Dim Red Light
n=14 Participants
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
|
|---|---|---|
|
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
|
1.77 score
Standard Deviation 3
|
Adverse Events
Bright White
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dim Red Light
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bright White
n=13 participants at risk
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.
|
Dim Red Light
n=14 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
headache
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
sleepiness
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Eye disorders
itchy eyes
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place