Partnering with NOCTEM® Health – developers of a clinical decision support platform designed to accelerate and facilitate the treatment of insomnia – Knowesis military research and program management experts work directly in support of the CDMRP JWMRP to:
- Develop, coordinate, and implement procedures for clinical human research involving cognitive behavioral therapy for insomnia.
- Collaborate with principal investigators, multidisciplinary staff, and other clinical and non-clinical programs and departments.
- Create, submit, and maintain documentation and materials for the institutional review board (IRB) and human research protection office (HRPO) to ensure research compliance.
- Present study methods, procedures, and risks to potential participants and obtain informed consent for interested and eligible individuals.
- Identify, report, and track potential problems with procedure compliance, data acquisition, technical procedures, or instrumentation.
- Manage and communicate with participants as they complete different phases of research protocols.
As noted, CBTI is the treatment of choice for chronic insomnia; however, CBTI remains underutilized and is often unavailable to Service Members due to: (1) Restricted availability of clinical expertise; (2) Rigid and resource-intensive treatment formats; and (3) Limited capacities for treatment precision. To overcome these obstacles, NOCTEM® developed and validated a Clinician Operated Assistive Sleep Technology (COAST™) platform that combines expertise in behavioral sleep medicine, digital health technology, and advanced machine learning. COAST consists of:
- Cloud-based clinician portal with embedded algorithms for the detection of sleep disordered patterns, clinical decision support tools and materials for the management of insomnia;
- Patient mobile app that requires a unique activation code for activation and includes daily sleep/wake logs, adherence measures, and weekly assessments of symptoms, side effects, and progress;
- A secure, HIPAA-compliant text messaging; and
- Easily generatable intervention reports that can be downloaded to facilitate documentation in DHA/DoD records.
The COAST portal allows clinicians to assess, monitor, and treat insomnia in real time remotely, as they receive daily patient sleep parameters, entered via the patient app. Clinicians who use COAST to deliver CBTI can serve 15 times more patients than possible with in-person CBTI. The work of Knowesis and NOCTEM® for this study is ongoing and evaluates the effectiveness of digital CBTI hubs as an augmentation strategy for military sleep clinics. Validation and implementation of this model could increase access to military insomnia related care, increase patient throughput, and decrease provider burnout resulting in a healthy and ready fighting force.
Joint Warfighter Medical Research Program
The mission of the Congressionally Directed Medical Research Program (CDMRP) is to responsibly manage collaborative research that discovers, develops, and delivers health care solutions for Service Members, Veterans and the American public. The Joint Warfighter Medical Research Program (JWMRP) augments and accelerates high priority Department of Defense (DoD) and Service medical requirements, serving to continue both Congressionally-directed and core prior year medical research and development initiatives that are close to achieving their objectives and yielding a benefit to military medicine. The JWMRP complements the CDMRDP and also addresses the requirements and needs of the DoD’s advanced product development community by facilitating further maturation of promising medical solutions through the acquisition process to support the Warfighter.
Chronic insomnia is pervasive among service members and adversely affects health and readiness. Prescription medications are the most common treatment strategy for insomnia, but side effects of these medications can include grogginess, impaired cognition, and slower reaction times. Cognitive Behavioral Treatment of Insomnia (CBTI) is the treatment of choice for chronic insomnia; however, CBTI remains underutilized and is often unavailable to Service Members for a variety of reasons.