Bright Light Treatment At Home To Manage Chronic Pain In U.S. Veterans
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: Rush University Medical Center

 
Bright Light Treatment At Home To Manage Chronic Pain In U.S. Veterans 
NCT02373189 
Document date: 12/23/22 
 

Protocol for ORA# 13082603: Bright Light Treatment at Home to Manage Chronic Pain in US Veterans 
 
 
 
 
 
 
 
 
 
 
 
Protocol 
A sample protocol for this pilot study is shown in the Figure above. On Day 1 (lab visit #1) subjects will 
complete questionnaires, receive a wrist activity monitor, and a Personal Data Assistant (PDA; electronic diary) 
to record their daily pain, mood, sleep, and substance use (alcohol, caffeine, prescribed and over the counter 
medication, heating pads, ice packs, etc) while they sleep ad lib at home, following their usual sleep schedule. 
They will then undergo pain sensitivity testing (acute pain induction with forearm ischemia and heat, between 
noon-1pm as per our pilot). On Day 8 (lab visit #2) subjects will complete questionnaires, have their diaries and 
wrist actigraphy data reviewed and then will undergo pain sensitivity testing again. Following this subjects will 
be trained in home saliva collection, receive a kit to take home and will complete their saliva collection that 
night. The following morning (Day 9, home visit #1) two research staff (mixed gender team) will visit the subject 
in their home to set up and instruct the subjects in the bright light treatment, and collect their saliva kit and 
samples. Subjects will self-administer the bright light for 1 h/morning for 6 days before returning to the lab (Day 
15, lab visit #3) for repeat questionnaires, review of their diaries and wrist actigraphy, pain sensitivity testing 
and issuing of the saliva collection kit. Research staff will again visit their homes to collect the saliva kit and 
samples (Day 16, home visit #2). After a further 7 days of bright light treatment, subjects will return for their last 
lab visit (Day 22, lab visit #4) for questionnaires, review of their diaries and wrist actigraphy, repeat pain 
sensitivity testing and issuing of the saliva collection kit. The following morning on Day 23 another home visit 
(home visit #3) will occur, and research staff will collect the light boxes, saliva kit, samples, and wrist monitors. 
The PDAs for electronic diaries will be left with the subject. During a 1 month follow up after cessation of the 
bright light treatment, subjects will continue to report their pain, mood and sleep once a day on the electronic 
diaries (once a day only to reduce burden and improve compliance). At the end of the follow up staff will collect 
the PDAs with electronic diaries during a final home visit.  
Amendment 3: there will be 1 more lab visit, approximately 2 weeks into the 30 day follow up to enable us to download 
data from the e-diary.  We will schedule this extra lab visit at a date and time convenient to the veteran to reduce their 
burden.  
 
Figure. A sample diagram for the 3 
week pilot protocol proposed in this 
R34 application. This protocol is for 
an average 12 to 8am sleeper. 
There will be 4 lab visits and 3 
home visits during the 3 week 
study. The grayed rectangles show 
when subjects will dim their lights at 
home for saliva collection, starting 
30 min before the first saliva 
sample. Each black dot is when a 
saliva sample is scheduled, starting 
6 h before habitual bedtime initially, 
thereafter 8 h before habitual 
bedtime to capture subsequent 
advances in the DLMO. The yellow 
rectangle indicates when the 1 
h/day bright light would occur, 
starting at habitual wake time, 
possibly earlier if required to fit into 
the subject’s daily schedule [4, 5].