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Digital Insomnia Intervention for Chronic Insomnia (SEDATIVE Trial)

N/A

Waitlist Available

Led By Adam D. Bramoweth, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24)

Awards & highlights

SEDATIVE Trial Summary

This trial will help assess whether an intervention combining evidence-based interventions for sedative-hypnotic reduction and behavioral interventions for insomnia delivered through a digital platform is feasible, acceptable, and effective for Veterans with chronic insomnia.

Who is the study for?

This trial is for Veterans at VA Pittsburgh Healthcare System who use sleep meds more than half the month for over 3 months and want to cut down or stop. They must have internet access on a mobile device. It's not for those with severe health issues, conditions worsened by sleep changes, high suicide risk, or recent substance abuse.Check my eligibility

What is being tested?

The study tests a digital program called COAST that combines cutting back on sleep meds with Cognitive Behavioral Therapy for Insomnia (CBT-I). Over 12 weeks, it aims to see if this approach is workable and helpful in improving Veterans' sleep and reducing their reliance on medications.See study design

What are the potential side effects?

Since the intervention involves therapy rather than medication, typical drug side effects are not expected. However, changing sleeping patterns could temporarily affect mood, alertness, or overall well-being.

SEDATIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insomnia Severity Index (ISI) Change

Sedative-Hypnotic Medication Use Change

Secondary outcome measures

Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change

Sleep Diary - Sleep Efficiency Change

Sleep Diary - Sleep Onset Latency (SOL) Change

+1 more

SEDATIVE Trial Design

1Treatment groups

Experimental Treatment

Group I: COAST + DeprescribingExperimental Treatment2 Interventions

CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy for Insomnia

2013

Completed Phase 3

~1800

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,560 Total Patients Enrolled

26 Trials studying Insomnia

4,154 Patients Enrolled for Insomnia

Adam D. Bramoweth, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

1 Previous Clinical Trials

4 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia Clinical Trial Eligibility Overview. Trial Name: NCT05027438 — N/A

Insomnia Research Study Groups: COAST + Deprescribing

Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05027438 — N/A

Cognitive Behavioral Therapy for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027438 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count of this research endeavor?

"Affirmative, the information available on clinicaltrials.gov indicates that this trial is presently recruiting participants. The study was first uploaded to the database on September 22nd 2022 and has been updated most recently on October 3rd. A total of fifty patients need to be recruited from one centre."

Answered by AI

What are the primary aims of this research endeavor?

"The primary aim of this clinical trial, which will be monitored at baseline (T0; week 0), post-treatment (T1; week 12) and 3 month follow-up (T2; week 24), is to evaluate the changes in Sedative Hypnotic Medication Use. Secondary objectives involve measuring alterations in Patient Reported Outcome Measurement Information System Adult Profile (PROMIS 29+2) Change, Sleep Diary - Wake After Sleep Onset (WASO) Change and Sleep Diary - Sleep Efficiency Change by assessing a variety of physical functions, social roles, cognitive functioning and other variables."

Answered by AI

Are new participants being accepted at this time for enrollment in the trial?

"According to clinicaltrials.gov, this medical research is presently accepting participants and was initially listed on September 22nd 2022 with the most recent update made on October 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

2022. "Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027438.

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