← Back to Search

Other

CBT-I or Sleep Medication for Chronic Insomnia (COZI Trial)

Phase 4
Waitlist Available
Led By Katie L. Stone, PhD
Research Sponsored by California Pacific Medical Center Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 9 weeks, 6 months, 9 months, 12 months
Awards & highlights

COZI Trial Summary

This trial is testing whether medication, cognitive-behavioral therapy, or a combination of both is more effective in treating chronic insomnia in men and women aged 18-80 living in rural areas.

Who is the study for?
This trial is for men and women aged 18-80 living in rural areas with chronic insomnia, who have regular internet access and a high Insomnia Severity Index score. It's not for those using sleep meds often, undergoing current insomnia therapy, or with severe mental/physical disorders including psychotic/bipolar disorders, substance use disorder, severe lung diseases, cognitive impairments, complex sleep behaviors or shift work at night.Check my eligibility
What is being tested?
The study compares three approaches: Internet-based Cognitive Behavioral Therapy (CBT-I), medications Zolpidem or Trazodone alone, and their combination to treat chronic insomnia. Participants will be randomly assigned to one of these treatments and followed up for a year to see which is most effective.See study design
What are the potential side effects?
Potential side effects may include daytime drowsiness, dizziness from the medications Zolpidem or Trazodone; CBT-I generally has no side effects but requires consistent participation in therapy sessions online.

COZI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.

COZI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 9 weeks, 6 months, 9 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 9 weeks, 6 months, 9 months, 12 months 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 Symptoms
Secondary outcome measures
Remission of Insomnia Symptoms
Treatment Response of Insomnia Symptoms
Other outcome measures
Anxiety and Depression
Cognitive Function
Daytime Sleepiness
+10 more

COZI Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CombinationExperimental Treatment3 Interventions
Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program
Group II: Medication (zolpidem or trazodone)Active Control2 Interventions
Zolpidem or trazodone, as prescribed by physician
Group III: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)Active Control1 Intervention
Internet-based CBT-I program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trazodone
2011
Completed Phase 4
~2380
Zolpidem
2003
Completed Phase 4
~2530

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER
514 Previous Clinical Trials
147,071 Total Patients Enrolled
California Pacific Medical Center Research InstituteLead Sponsor
43 Previous Clinical Trials
11,326 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,995,348 Total Patients Enrolled

Media Library

Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04468776 — Phase 4
Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468776 — Phase 4
Chronic Insomnia Research Study Groups: Medication (zolpidem or trazodone), Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), Combination
Chronic Insomnia Clinical Trial 2023: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT04468776 — Phase 4

Frequently Asked Questions

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

What is the total number of individuals participating in this experiment?

"Affirmative. Clinicaltrials.gov corroborates the fact that this research initiative, which was created on February 25th 2022, is actively recruiting participants. 1200 individuals need to be recruited from 8 distinct medical sites."

Answered by AI

What criteria must a participant fulfill to be eligible for this investigation?

"This experiment is open to 1200 individuals aged 18-80 who struggle with insomnia. The eligibility criteria also call for participants to receive primary care in a rural area, have regular access to the internet and computers, as well as an Insomnia Severity Index score of greater than 10."

Answered by AI

To what extent has Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) shown to be effective in treating sleep disorders?

"CBT-I is frequently used to quell pain, but it has been found effective in managing the symptoms of schizophrenia, eating disorders, and Alzheimer's disease (AD)."

Answered by AI

Could you please outline any prior research projects conducted with Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)?

"Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) was pioneered in 2017 at the John D. Dingell VA Medical Center and has since been studied 109 times, with 12 active trials currently taking place primarily in Tucson, Arizona."

Answered by AI

Are there any participating healthcare facilities running this investigation in North America?

"This clinical trial is being conducted in 8 locations, some of which are the University of Arizona in Tucson, University of Alabama at Birmingham in Birmingham, and University of Missouri in Columbia."

Answered by AI

Is the inclusion criterion for this trial restricted to individuals younger than 40?

"To be eligible to join this trial, one must be between 18 and 80 years old. For those under the age of 18 or over 65, there are 19 trials and 170 trials respectively available for them."

Answered by AI

Could engaging in Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) prove to be a risk factor for patients?

"The team of experts at Power have concluded that the safety rating for Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) is a 3, as this treatment has already been approved following multiple round of testing."

Answered by AI

Are there any vacancies available to participate in this research?

"This clinical trial is actively searching for participants, as indicated by the data hosted on clinicaltrials.gov. It was first introduced to the public on February 25th 2022 and has been updated most recently of June 10th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
New Hampshire
Oregon
How old are they?
18 - 65
What site did they apply to?
National Jewish Health
Oregon Health & Science University
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I currently take medication to go to sleep, but I wake up every 2 to 3 hours during the night. Then, I take Modafinil during the day to keep me awake. This is no way to live.
PatientReceived 2+ prior treatments
~0 spots leftby May 2024