CompletedNot Applicable

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

United States36 participantsStarted 2022-09-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insomnia Severity Index (ISI) Change

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Sedative-Hypnotic Medication Use Change

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Trial details

NCT IDNCT05027438

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-03-31

Results submitted2025-03-04

View on ClinicalTrials.gov More Insomnia trials