Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform

Last updated: March 19, 2024
Sponsor: Noctem, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Restless Leg Syndrome

Insomnia

Treatment

External Facilitation Support

No Facilitation Support

External and Internal Facilitation Support

Clinical Study ID

NCT04366284
2019-406
MT190002.01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.

Eligibility Criteria

Inclusion

Inclusion Criteria: For clinicians:

  • Completion of the first half of the workshop or similar Behavioral Sleep Medicineworkshop in the past 6 months
  • Completion of the second half of the workshop, including a training session to learnabout the use of the NOCTEM platform
  • See patients who present with insomnia
  • Use cognitive-behavioral techniques as part of their practice For patients:
  • Are service members, veterans, or adult dependents who receive behavioral health careat one of the participating sites
  • Present with complaints of insomnia
  • Own a smart phone or smart device
  • Deemed suitable by their clinician to receive the sleep intervention via the NOCTEMplatform
  • Confirm their willingness to use the NOCTEM app for sleep care with their provider

Exclusion

Exclusion Criteria: For clinicians:

  • Do not provide direct behavioral health care to service members
  • Do not complete the two-part workshop and the 2-week proficiency training For patients (recommended):
  • Suspected, diagnosed, or inadequately untreated sleep apnea (less than 4 hours ofcontinuous positive airway pressure [CPAP] use per night)
  • Psychotic symptoms
  • A history of bipolar disorders
  • Women who are pregnant or breastfeeding and parents of children younger than 3 monthsof age

Study Design

Total Participants: 17
Treatment Group(s): 3
Primary Treatment: External Facilitation Support
Phase:
Study Start date:
September 01, 2020
Estimated Completion Date:
September 30, 2024

Study Description

Insomnia and other sleep disorders are highly prevalent among military service members and compromise readiness, health, and performance; increase the risk of injury; and are associated with astronomical healthcare costs. The first-line treatment recommended for insomnia is cognitive-behavioral treatment for insomnia (CBTI). However, the large number of service members who are in need of this treatment outnumber the clinicians who are experts in behavioral sleep medicine and who currently provide this intervention in a cost-efficient manner and in a way that is acceptable and accessible to patients and clinicians. To address this challenge and scale the delivery and access to evidence-based behavioral sleep interventions, NOCTEM™ has developed a digital health platform called COAST (Clinician Operated Assistive Sleep Technology). However, the most effective way to implement the use of digital sleep health technology, and its comparative impact on patient outcomes, remain to be determined. Therefore, this trial will compare three different ways to deploy the NOCTEM™ platform among behavioral health care providers who encounter patients with insomnia. Specifically, the study will evaluate and compare without external or internal support (NOCTEM), with external support (i.e., facilitation) offered by the NOCTEM team (NOCTEM+EF), and with external support and internal support from local champions (NOCTEM+EF/IF). The trial will also compare the overall magnitude of improvements in insomnia among patients who use the NOCTEM app with their provider.

Connect with a study center

  • Naval Health Research Center

    San Diego, California 92152
    United States

    Site Not Available

  • Pope Army Airfield

    Pope Field, North Carolina 28307
    United States

    Site Not Available

  • Lackland Air Force Base

    San Antonio, Texas 78236
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431
    United States

    Site Not Available

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