Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02484742 |
| Other study ID # |
2014P000354 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
March 2019 |
Study information
| Verified date |
July 2019 |
| Source |
Beth Israel Deaconess Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main purpose of this study is to learn about the effects of repeated exposure to sleep
disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep
is shortened and disrupted, followed by a single night of recovery sleep) on inflammation,
mood, and pain processing (experiences/perceptions of pain). Purpose of this research project
is to understand the mechanisms of how sleep disruption may change mood and the experience of
pain. Understanding those mechanisms is important to develop interventions that may help to
reduce the effects of sleep disruption on mood and pain.
Description:
1. Screening Procedures: For this research study, the screening procedures include the
following activities. Participants will first complete questionnaires and have an
interview where they will be asked questions concerning general health status and
sleep-wake habits. Also during this visit, a study nurse will collect a small blood
sample that will be used to test for a number of markers of general health status.
If it appears that the participant may be eligible for participation, s/he will be
introduced to an electronic diary that will be emailed every morning and evening to
monitor sleep-wake patterns, mood, pain, and other health-related information.
Following the medical screening (visit 2), the physician will determine if the
participant is eligible to proceed to the overnight sleep study. This consists of
sleeping overnight in the laboratory during the usual sleep time.
Seven days before participation in the in-hospital portion of the study, a member of the
study team will ask the participant to follow the study sleep-wake schedule. Sleep will
be monitored with an electronic sleep diary and the participant will wear an actigraphy
watch, which will help to evaluate sleep and measure the light level exposure before
starting the study.
2. Randomization Procedures: Each participant will complete both parts of the study
protocol, i.e., the experimental condition (where participants will undergo repeated
cycles of sleep disruption, 18 days total in the Clinical Research Center) and the
control condition (where participants will have a sleep opportunity of 8 hours every
night; 18 days total in the Clinical Research Center).
3. Research Procedures: If a participant qualifies to take part in this research study,
s/he will be required to stay in the hospital for two 18 day long research protocols.
These protocols will take place at least 2-3 months apart. The experimental protocol
includes 3 nights of 8 hour-sleep per night followed by three 4-day cycles, each
consisting of 3 nights of shortened and disrupted sleep, followed by a single night of 8
hour recovery sleep. After the last cycle, the participant will have two more nights
with 8 hours of sleep per night. In the control protocol, these 18 days will be 8-hour
sleep nights.
During the stay in the hospital, research staff will accompany the participant during
all waking times. The staff will help the participant to stay on the schedule, maintain
wakefulness, and make sure that equipment is recording properly.
Both study protocols will begin with two adaptation nights. On the first day of the
protocol, the participant will be told the sleep condition to be assigned first: the
sleep disruption condition or the sleep control condition.
During the sleep disruption nights, sleep onset will be delayed by one hour (midnight
12am), and sleep offset (final wake up) will be advanced by one hour (6am). The sleep
period (12-6am) will be disrupted hourly by 20 minute long awakenings. During the
nighttime periods, the nurse will measure blood pressure and collect a small sample of
your saliva. The participant will also be asked to complete tests that assess well-being
and cognitive functioning (such as attention, learning).
After the last day of the third cycle, the participant will have four nights with 8
hours of sleep per night. The participant will be able to leave the research center in
the morning after the 18th night.
During each of the two 18-day stays in the hospital, participants will wear an
actigraphy watch on all study days, which will help to evaluate sleep and measure the
light level exposure. The participant will also have two blood draws obtained by a
simple needle stick on intermittent days. Additionally, during these 24-hour periods,
the study team will be collecting sleep recording data (using a polysomnography device
over a 24-hour period). Finally, the study team will collect urine samples over the
course of this protocol.
Blood pressure will be measured at frequent intervals through the study. Computerized
performance tests will be conducted at frequent intervals through the study. One of the
tests involves measurement of reaction time by having participants press a button on a
little box. In another performance test the study team will ask the participant to press
the right or left mouse button depending on whether the word on the computer screen is
printed in the same color or in a different color; this should be done as quickly and as
accurately as possible. In addition, we will ask participants to rate well-being at
frequent intervals throughout the stay in the Clinical Research Center.
On several days during the stay in the Clinical Research Center, the investigators will
test the perception of pain. During pain testing, the participant will remain in a
comfortable chair throughout the testing session. The testing will consist of measures
of pain threshold (first feeling of the sensation of pain to a heat or mechanical
stimulus), pain tolerance (when the pain sensation feels intolerable), and pain
modulation (how the central nervous system can change the perception of pain).
4. Monitoring/Follow-Up Procedures. For this research study, the monitoring/follow-up
procedures include meeting with one of the lead members of the study team on the last
day of each of the 18-day protocols. During this time, a study team member will discuss
the participant's study experience and will give the opportunity to ask any questions
concerning the study.
