Comparing standard insomnia care to a digital treatment approach
Comparing Insomnia Care As Usual to Digital Augmentation
This study is testing if a digital treatment for insomnia works just as well as regular care for active duty service members who have chronic insomnia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Noctem, LLC Industry-sponsored |
| Locations | 1 site (Lakewood, Washington) |
| Trial ID | NCT05490550 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a digital platform against traditional insomnia care in military treatment facilities. It focuses on active duty service members diagnosed with chronic insomnia, assessing changes in insomnia severity, depression, anxiety, and patient satisfaction. The study utilizes the Clinician Operated Assistive Sleep Technology (COAST™) platform to enhance the delivery of CBTI. Participants will be monitored pre-treatment, post-treatment, and at a 3-month follow-up to determine the non-inferiority of the digital approach compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are active duty service members aged 18 or older with a diagnosis of chronic insomnia who are eligible for CBTI.
Not a fit: Patients with untreated or under-treated comorbid sleep disorders that require independent treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve access to effective insomnia treatment for service members, enhancing their overall health and readiness.
How similar studies have performed: Other studies have shown promise in using digital health technologies for behavioral health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician. * Age 18 or older. * Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures. * If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks) * Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system) Exclusion Criteria: * Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others. * Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study. * Having planned or attempted suicide or the harming of others in the past 6 months. * Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care. * Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living. * Active substance use disorder. * Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders. * Currently pregnant, breastfeeding, or being the parent of a newborn \< 3 months old. * Untreated seizure disorder. * Suspected, diagnosed, or inadequately treated sleep apnea (less than 4 hours of CPAP use per night). * Anticipates relocating/moving out of state in the next 3 months
Where this trial is running
Lakewood, Washington
- Madigan Army Medical Center — Lakewood, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Anne Germain — Noctem, LLC
- Study coordinator: Anne Germain, PhD
- Email: anne@noctemhealth.com
- Phone: (412) 897-3183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.