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Eszopiclone for Obstructive Sleep Apnea (TOP-CPAP Trial)
Phase 2
Recruiting
Led By Christopher N Schmickl, MD, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 21-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 2-14 after initiation of study drugs
Awards & highlights
TOP-CPAP Trial Summary
This trial aims to improve CPAP-adherence for 10% of US population with OSA, with better outcomes & care.
Who is the study for?
This trial is for adults aged 21-65 with a physician's diagnosis of obstructive sleep apnea (OSA), BMI under 32, and who use CPAP machines for 0.5-4 hours per night but want to continue trying CPAP. Excluded are those with significant side effects from CPAP, uncontrolled medical conditions, substance abuse, certain sleep disorders, or safety concerns.Check my eligibility
What is being tested?
The TOP-CPAP study tests whether taking Eszopiclone—a hypnotic drug—can help people with OSA adhere better to their CPAP therapy by targeting the underlying cause of their condition. It's a randomized controlled trial comparing Eszopiclone against a placebo.See study design
What are the potential side effects?
Eszopiclone may cause drowsiness during the day, dizziness, dry mouth or throat irritation. Some individuals might experience changes in mood or behavior and complex behaviors like driving while not fully awake after taking it.
TOP-CPAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
TOP-CPAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 2-14 after initiation of study drugs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 2-14 after initiation of study drugs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean use per night of continuous positive airway pressure (CPAP)
Secondary outcome measures
Alternative measures of CPAP usage
Apnea Hypopnea Index
Epworth Sleepiness Scale (ESS)
+5 moreOther outcome measures
Average total sleep time per night
Sleep Apnea Traits with special focus on arousal threshold
Side effects data
From 2010 Phase 2 & 3 trial • 192 Patients • NCT007705104%
Dizziness
4%
Somnolence
1%
Dysgeusia
1%
Dermatitis Contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zolpidem Tartrate 10 mg
Eszopiclone 1 mg
Eszopiclone 2 mg
Eszopiclone 3 mg
Placebo
TOP-CPAP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EszopicloneExperimental Treatment1 Intervention
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eszopiclone 2 mg
2008
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,520,994 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
22 Previous Clinical Trials
2,588 Total Patients Enrolled
Christopher N Schmickl, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience more than 3 issues with my CPAP machine.You have a serious sleep disorder or walk in your sleep as an adult.You are allergic to the study drug.Your body mass index is less than 32.I regularly use opioids or benzodiazepines.I am willing to keep using CPAP for my condition.I have been diagnosed with sleep apnea based on a sleep study in the last 2 years.I am able to understand and consent to the study, and can follow the study procedures.You have a tracheostomy.You are currently using illegal drugs or drinking more than 3 ounces of alcohol every night.I have not been treated for any sleep disorders like narcolepsy or restless legs.I am unable to complete English-only study materials.I was hospitalized in the last 3 months.I am between 21 and 65 years old.You have frequent breathing interruptions during sleep, as measured by a sleep study.I have tried using a CPAP machine for at least one month.I am currently taking a medication for sleep regularly.You use a CPAP machine for at least half an hour to four hours every night, as shown by the data that can be checked from a distance.You have a high risk of falling asleep during the day, work in a job where safety is very important, have had a car accident because of sleep, or have low oxygen levels during sleep or when awake.
Research Study Groups:
This trial has the following groups:- Group 1: Eszopiclone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially become involved in this trial?
"To be suitable for this sleep apnea study, patients must have the condition and fall between 21-65 years old. This trial is currently recruiting a total of 50 individuals."
Answered by AI
Does this research study encompass individuals beyond the age of eighty-five?
"According to the criteria of this clinical trial, the lower age limit for enrollment is 21 years old while the upper limit is 65."
Answered by AI
Is Eszopiclone a reliable treatment option with minimal risk?
"Evidence of safety makes us rate Eszopiclone a 2, as this medication has only gone through Phase 2 trials and thus far no efficacy data exists."
Answered by AI
Are there vacancies in this trial for participants to join?
"Unfortunately, the study is not in need of applicants at this time. According to clinicaltrials.gov, the trial was announced on August 1st 2023 and recently updated on July 10th 2023; however, there are 262 other medical studies that are still actively recruiting patients."
Answered by AI
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