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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 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Awards & highlights
VicTor Trial Summary
This trial tests a drug to treat Obstructive Sleep Apnea, using a controlled study with participants taking placebo and the drug.
Eligible Conditions
- Obstructive Sleep Apnea
VicTor Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
VicTor Trial Design
6Treatment groups
Experimental Treatment
Group I: Order: Period C, Period B, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group II: Order: Period C, Period A, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group III: Order: Period B, Period C, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group IV: Order: Period B, Period A, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group V: Order: Period A, Period C, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group VI: Order: Period A, Period B, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Period C
2023
Completed Phase 2
~30
Period A
2023
Completed Phase 2
~30
Period B
2023
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
ApnimedLead Sponsor
13 Previous Clinical Trials
2,010 Total Patients Enrolled
Ronald Farkas, MDStudy DirectorApnimed Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial seek out elderly participants?
"As per the outlined requirements, individuals aged 18 and above but below 75 may join this medical experiment."
Answered by AI
Do I meet the criteria to participate in this clinical trial?
"This sleep apnea trial is searching for between 18 and 75 year olds, with a total of 20 participants required."
Answered by AI
Could you please elucidate the potential harms associated with Order: Period A, Period B, and Period C?
"Our safety assessment of Periods A, B and C scored a 2 since there is data to support its security but no evidence yet demonstrating the intervention's efficacy."
Answered by AI
Is enrolling in this clinical trial an option for potential participants?
"It appears that, as of March 30th 2023, this research trial is not currently recruiting participants. Clinicaltrials.gov indicates the study went live on April 1st 2023 and has yet to resume recruitment; however there are 256 other experiments actively searching for volunteers now."
Answered by AI
Who else is applying?
What state do they live in?
California
Missouri
Other
Illinois
What site did they apply to?
Santa Monica Clinical Trials
Brigham and Women's Hospital
Clayton Sleep Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
Why did patients apply to this trial?
I would love to get a full nights rest and of course stop snoring. I faithfully use my CPAP! Can this treatment help people who won't use a CPAP.
PatientReceived no prior treatments
I have had sleep issues since 2008, tried several different methods and pills. I have a Cpap, but definitely not fond of it. Doesn't control the many nights of the inability to go to sleep. Have started taking 3mg of Melatonin. Also have trazadone 1/2 tab I can take too. These two are my primary care doctor's help. The cpap and 2-4 x's appt with the OSF Sleep Center are supposed to help, but haven't had 7 nights of good sleep in years. I may get 2-3 but then have nights of not going to sleep till after 3 am.
PatientReceived 2+ prior treatments
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