N/A
Completed N=36
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
Source: ClinicalTrials.gov NCT05027438 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Insomnia Severity Index (ISI) Change — 14.63; 6.13; 7.17 score on a scale — p=<0.001
Summary
Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia [CBT-I]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.
Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.
Aim 2: To assess Veteran acceptability and usability of the COAST platform.
Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) Change |
14.63; 6.13; 7.17 | <0.001 sig |
| PRIMARY Sedative-Hypnotic Medication Use Change |
100; 41.45; 37.74 | 0.004 sig |
| SECONDARY Sedative-Hypnotic Medication Cessation |
7; 12 | 0.052 |
| SECONDARY Sleep Diary - Sleep Onset Latency (SOL) Change |
34.19; 20.02; 20.11 | <0.001 sig |
| SECONDARY Sleep Diary - Wake After Sleep Onset (WASO) Change |
26.04; 14.68; 11.04 | 0.101 |
| SECONDARY Sleep Diary - Sleep Efficiency Change |
87; 93; 94 | <0.001 sig |
| SECONDARY Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change |
51.58; 48.48; 48.39; 45.46; 48.46; 49.98 | <0.001 sig |
| SECONDARY Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) |
0.29; 0.41; 0.50 | 0.22 |
Eligibility Criteria
Inclusion Criteria
- A Veteran receiving care at VA Pittsburgh Healthcare System
- Active sedative-hypnotic medication use >14 days/month for >=3 months
- A desire to reduce or stop using sedative-hypnotic medications
- Access to a mobile device with internet
Exclusion Criteria
- A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression)
- A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)
- High risk of suicide
- An active substance use disorder in past 6 months
Data sourced from ClinicalTrials.gov (NCT05027438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.