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CBT-I or Sleep Medication for Chronic Insomnia (COZI Trial)
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.
COZI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOZI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COZI Trial Design
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Who is running the clinical trial?
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- You are currently struggling with substance addiction.I have had a fracture or a serious fall in the last year.You have serious mental or physical problems that would make it hard or unsafe for you to take part in the study.You have bipolar disorder.I work night shifts between 12:00 a.m. and 6:00 a.m.I have severe lung problems like COPD, asthma, or lung fibrosis.You have a mental illness that causes you to lose touch with reality.I have been diagnosed with cognitive impairment or dementia.I am between 18 and 80 years old.Your score on the Insomnia Severity Index is higher than 10.You have a history of doing unusual or dangerous things while asleep, either on your own or while under the influence of sleep medications.I have trouble falling asleep until very late.I am currently receiving therapy for insomnia.You have taken sleeping pills more than twice in the past week.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Medication (zolpidem or trazodone)
- Group 2: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Group 3: Combination
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Frequently Asked Questions
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."
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."
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)."
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."
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."
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."
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."
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."
Who else is applying?
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