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Combination Drug Therapy for Obstructive Sleep Apnea (RESCUE-Combo Trial)
Phase 2
Recruiting
Led By Christopher 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 nights
Awards & highlights
RESCUE-Combo Trial Summary
This trial will test a combination of three drugs to see if they're more effective in treating obstructive sleep apnea than single-drug therapies.
Eligible Conditions
- Obstructive Sleep Apnea
RESCUE-Combo Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 nights
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 nights
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) during supine Non-Rapid Eye Movement (NREM) sleep
Secondary outcome measures
Blood Pressure
Pathophysiological Traits
Percent Responders
+4 moreRESCUE-Combo Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo, then Dual-Therapy, then Single/Triple-TherapyExperimental Treatment4 Interventions
Subjects will start with a 3-day PLACEBO regimen:
Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.
Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.
Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then cross-over to a 3-day EXPERIMENTAL DUAL-regimen:
Day 1: Acetazolamide 250mg at bedtime at home.
Day 2: Acetazolamide 500mg at bedtime at home.
Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:
Day 1: Acetazolamide 250mg at bedtime at home.
Day 2: Acetazolamide 500mg at bedtime at home.
Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively.
Group II: Dual-Therapy, then Placebo, then Single/Triple-TherapyExperimental Treatment4 Interventions
Subjects will start with a 3-day EXPERIMENTAL DUAL-regimen:
Day 1: Acetazolamide 250mg at bedtime at home.
Day 2: Acetazolamide 500mg at bedtime at home.
Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then cross-over to a 3-day PLACEBO regimen:
Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.
Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.
Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:
Day 1: Acetazolamide 250mg at bedtime at home.
Day 2: Acetazolamide 500mg at bedtime at home.
Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eszopiclone
FDA approved
Acetazolamide
FDA approved
Placebo
1995
Completed Phase 3
~2670
Venlafaxine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,387 Total Patients Enrolled
Christopher Schmickl, MD, PhDPrincipal Investigator - Associate Physician and Postdoctoral Fellow
Regents Of The University Of California -Ucsd Physician Assoc, Regents of the University of California - UCSD Medical Group, UC San Diego Health System-Hillcrest, UCSD Medical Center-Hillcrest
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate or severe untreated sleep apnea with specific measurements showing how often you stop breathing during sleep.You have a disorder that affects your body's natural sleep-wake cycle.You have long-term liver disease or kidney disease in its final stage.You have a psychiatric disease, except for well-controlled depression or anxiety.You are consistently using a treatment that effectively manages obstructive sleep apnea.You have any untreated sleep disorder that causes frequent disruptions in your sleep, like periodic limb movement disorder or narcolepsy.You have a tracheostomy.You had stomach surgery to help with weight loss.You regularly take certain medications that can affect your breathing control.Your body mass index (BMI) is between 18 and 40.You cannot take the study drugs if you are allergic to any of them, have certain medications in your system, or have severe nighttime breathing problems.You have not had surgery to improve blood flow to your heart, or you have a history of chest pain, heart attack, stroke, or heart failure.Your blood pressure is very high and not controlled with medication.You are taking certain medications that have similar effects to the study drug.You can't sleep on your back for overnight sleep tests.You had stomach or intestinal bleeding or ulcers in the past 5 years.You currently use illegal drugs or drink more than 2 drinks of alcohol per day.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo, then Dual-Therapy, then Single/Triple-Therapy
- Group 2: Dual-Therapy, then Placebo, then Single/Triple-Therapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04639193 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to be a part of this medical experiment?
"To participate in this trial, patients should have a confirmed case of sleep apnea and must be between 18-65 years old. This clinical study is limited to 20 participants in total."
Answered by AI
What therapeutic purposes does Venlafaxine typically serve?
"Venlafaxine is a common pharmaceutical for sleep-related issues. Additionally, it can be helpful in treating breast cancer, hormonal shifts during menopause, and metabolic alkalosis."
Answered by AI
What is the current population sample size of this trial?
"Affirmative. The clinical trial, first posted on January 1st 2020 and recently updated in September 2021 according to data hosted by clinicaltrials.gov, is actively searching for recruits. Only 20 participants are needed from 2 medical centres."
Answered by AI
Has Venlafaxine previously been assessed through clinical experimentation?
"Currently, there are 27 active trials for Venlafaxine with 9 of those being in Phase 3. Salt Lake City, Utah is the main hub for these studies; however, 78 other medical centres across the nation have begun research related to this drug as well."
Answered by AI
Are there any vacancies for involvement in this research study?
"Affirmative. As evidenced by records documented on clinicaltrials.gov, this research is recruiting participants at present. This study was first published on the 1st of January 2020 and has been amended as recently as September 22nd 2021, with a target recruitment count of 20 individuals from 2 respective locations."
Answered by AI
Does the use of Venlafaxine present any potential safety risks?
"With Phase 2 clinical trials providing evidence of safety, but no data yet on efficacy, our analysts at Power estimated the security of venlafaxine to be a score of 2."
Answered by AI
Is the minimum age requirement for this investigation below sixty years?
"This research project is open to individuals aged 18 or older and below the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UCSD Health - Pulmonary and Sleep Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've never tried a drug for my sleep apnea. But I hate using my CPAP machine. I have sleep apnea due to a pain patch that I wear-Butrans, so I don't know if I qualify for you study.
PatientReceived 2+ prior treatments
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