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
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
Connect with a study center
Naval Health Research Center
San Diego, California 92152
United StatesSite Not Available
Pope Army Airfield
Pope Field, North Carolina 28307
United StatesSite Not Available
Lackland Air Force Base
San Antonio, Texas 78236
United StatesSite Not Available
Madigan Army Medical Center
Tacoma, Washington 98431
United StatesSite Not Available

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