Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04150718 |
| Other study ID # |
832986 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2020 |
| Est. completion date |
July 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The hypothesis underlying this proposal is that deficits of synaptic plasticity underlie the
slow-wave activity (SWA) abnormalities observed n major depressive disorder (MDD), and that
manipulating SWA may serve to circumvent these deficits by facilitating an increase in
synaptic strength via the inhibition of synaptic down-scaling, thereby improving plasticity
and mood.
Description:
VISIT 1: Screening. Participants who meet initial inclusion criteria via phone screen will be
invited to the laboratory for an in-person screening visit that includes additional screening
(e.g. Medical history, TMS eligibility, hearing test for SW disruption procedure), and a
structured clinical interview to determine final study eligibility. All subjects will receive
verbal and written explanation of the general goals and risks of the study and will sign an
informed consent. At this session, participants will also have the opportunity to become
acquainted with the TMS and SW disruption procedures. In the case that remote visits are
being utilized, such as during the COVID-19 pandemic, this will be separated into a virtual
visit (consent, clinical interview, etc. - anything that can be conducted remotely will be)
and an in-person visit (hearing test, TMS demonstration). Participants will also choose two
dates, at least two nights apart and at most separated by two weeks, for the in-lab visits.
At-home Sleep Recording. For 7 days prior to the in-lab study visits, participants will be
asked to keep a consistent at-home sleep schedule, based on habitual rise time (e.g., 10:30
PM - 6 AM). Participants will also consent to refraining from napping, using alcohol and
drugs, and limiting caffeine use to one caffeinated beverage before noon throughout the
study. These procedures will be confirmed using actigraphy, and sleep diary. Actigraphy
provides a validated measure of sleep-wake patterns based on light and activity levels
utilizing a wrist-watch like device (Actiwatch 2 and Actiwatch Spectrum Pro, Philips
Respironics, Inc.). Sleep diaries will be used to document bedtime and rise time, and several
other sleep parameters. Participants will also be asked to note if actigraphs were removed,
for how long and for what purpose. Sleep diaries will be completed via the REDCap web-based
application if participants have consistent Internet access. Paper and pencil versions of
sleep diaries will also be available. Study staff will compare across these methods to verify
adherence to study guidelines prior to the in-lab study.
VISIT 2: Baseline Night. Visit 2 and Visit 3 occur on two separate days, in a counterbalanced
design to ensure no order or learning effects. The following procedure description will occur
in half of participants where Visit 2 precedes Visit 3; however identical procedures will be
used for the remaining half of participants where Visit 3 will precede Visit 2. Participants
will arrive at the Clinical Research Center for Sleep (CRCS) at 8pm on Visit 2. Following
their arrival and orientation, EEG electrodes will be applied. Participants sleep will then
be monitored overnight. In the morning, participants will have their blood drawn, and after a
light breakfast, the HAM-D will be administered, and then participants will be asked to fill
out mood questionnaires (BDI, VAS, PANAS, KSS), and complete a battery of tasks including
memory tasks, and resting EEG. They will then be accompanied to the Richards Building to
complete the TMS protocol, before returning to the CRCS.
VISIT 3: Slow-wave Disruption. Procedures for Visit 3 are identical for those for Visit 2,
with the exception of the following: Utilizing real-time EEG monitoring during sleep, left
(C3) and right central (C4) channels will be continuously inspected. Whenever two delta waves
(14 Hz; 75 V) appear within 15 seconds, an acoustic stimulus (i.e. tone; frequency = 1000 Hz;
intensity = 20100 dB) will be administered through a speaker mounted above the bed, beginning
with the lowest intensity (20 dB) and increased by 5 dB intervals if no response occurs
(sleep stage shift, K complex, EEG desynchronization, mixed and fast frequency, alpha burst,
muscle tone increase, slow eye movements). Utilizing this methodology, the type and incidence
of tones played will be tailored to each participant to suppress slow waves without arousing
the subject. Disruption of SWA will take place without waking the subject or decreasing total
sleep time. The selective SW disruption procedure has been described in detail elsewhere.
TMS The TMS system is housed in the Richards Biomedical Building. Only individuals trained by
the IDE sponsor (Desmond Oathes, Ph.D.) and Center Director (Yvette Sheline, M.D.) will
dispense TMS. Since all TMS procedures are being conducted in Dr. Sheline's lab, all plans
for receipt, storage, labelling, dispensing, returning of failed devices, and destruction
will fall under the center's SOPs.
