Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06041581 |
Other study ID # |
17650 |
Secondary ID |
R01HL165115 |
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 25, 2024 |
Est. completion date |
July 31, 2027 |
Study information
Verified date |
June 2024 |
Source |
Indiana University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia
represent a large group of people at elevated risk of developing CVD in the future. This
clinical trial will determine if our updated insomnia treatment, called the SHADES
intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these
improvements are due to positive changes in sleep factors. A total of 200 primary care
patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES
intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for
insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and
primary care for insomnia). Before and after treatment, participants will complete
measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic
dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms,
sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether
the SHADES intervention produces greater improvements in the CVD factors than the active
control condition.
Description:
Cardiovascular disease (CVD) affects nearly 1 in 2 U.S. adults, is the #1 killer of men and
women, burdens disadvantaged groups, and has costs greater than any other condition. While
these statistics highlight the importance of CVD prevention, current approaches have only
partial effectiveness. This has created a need to identify new CVD prevention targets, their
underlying mechanisms, and effective interventions. Insomnia, its candidate mechanisms, and
insomnia treatment are strong candidates in this regard. Thirty years of evidence indicates
that insomnia is an independent, clinically important, robust, and potentially causal and
modifiable risk factor for CVD. In addition, biologically plausible mechanisms that could
explain how insomnia promotes the development of CVD have been proposed, with the most
strongly supported being systemic inflammation, autonomic dysfunction, and metabolic
dysregulation. Because insomnia now receives limited attention in settings where CVD
prevention occurs (e.g., primary care), there is a large cohort of patients with an
unaddressed CVD risk factor (insomnia). This status quo and the strong state of the
insomnia-to-CVD science create the current need for a well-powered, mechanistic trial to
elucidate biological mechanisms underlying the insomnia-to-CVD relationship and the
mechanisms of action of cognitive-behavioral therapy for insomnia (CBT-I), both of which are
presently unknown. Therefore, we are conducting a mechanistic trial of 200 primary care
patients (45% minority) with insomnia and CVD risk factors but no clinical CVD. Participants
will be randomized to 6 months of the SHADES (Strengthening Hearts by Addressing DisruptEd
Sleep) intervention or the active control condition. The SHADES intervention is our
modernized collaborative care intervention consisting of well-established internet,
telephonic, and/or face-to-face CBT-I. The active control condition consists of sleep
education/hygiene, symptom monitoring, and primary care for insomnia. Our proposal has four
aims - Aim 1: determine the effect of the SHADES intervention on our primary CVD mechanism of
high-sensitivity CRP; Aim 2: determine the effect of the SHADES intervention on our secondary
CVD mechanisms of systemic inflammation, autonomic dysfunction, and metabolic dysregulation;
Aim 3: examine if 6-month improvements in upstream sleep mechanisms mediate the SHADES
intervention effect on 6-month improvements in downstream CVD mechanisms; Exploratory Aim:
explore the effect of the SHADES intervention on proinflammatory gene expression. This trial
could generate the critical support for the mechanistic rationale and conceptual framework
needed to justify the next-step phase III, multi-site clinical trial to determine the SHADES
Intervention effect on CVD clinical outcomes, endpoints of great public health relevance,
morbidity, and cost.