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Combination Drug Therapy for Obstructive Sleep Apnea (RESCUE-Combo Trial)
Phase 2
Waitlist Available
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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial tests a combination of three drugs to treat sleep apnea in patients who can't use standard treatments like CPAP. The drugs work together to improve breathing and sleep quality.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 nights
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 nights
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apnea Hypopnea Index (AHI)
Secondary study objectives
Blood Pressure
Pathophysiological Trait: Loop Gain
Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold
+6 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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?
American Thoracic SocietyOTHER
10 Previous Clinical Trials
630 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,026 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:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
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