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Rescue Pharmacotherapy for Obstructive Sleep Apnea (RescOSA Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 night
Awards & highlights
RescOSA Trial Summary
This trial is testing whether adding a drug to the treatment regimen of people who haven't responded to other treatments can help them. The drugs being tested are acetazolamide, atomoxetine-plus-eszopiclone, or trazodone.
Who is the study for?
This trial is for individuals with persistent obstructive sleep apnea (OSA) who haven't found relief through mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). Participants must have a residual AHI of ≥15 events/hr despite these treatments. People with certain medical conditions, including severe liver or kidney issues, specific heart problems, glaucoma, and those on conflicting medications like SSRIs/SNRIs are excluded.Check my eligibility
What is being tested?
The study tests whether adding one of several drugs—acetazolamide, atomoxetine-plus-eszopiclone, trazodone—or a placebo can improve OSA in patients unresponsive to MAD or HGNS. Each drug targets different physiological traits contributing to OSA such as high loop gain or low arousal threshold.See study design
What are the potential side effects?
Potential side effects include acid-base balance issues and electrolyte disturbances from acetazolamide; dry mouth, constipation, increased heart rate from atomoxetine; drowsiness from eszopiclone; and sedation or cardiac changes from trazodone. Individual reactions may vary.
RescOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My sleep apnea treatment with a device hasn't reduced my symptoms enough.
RescOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 night
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 night
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, Events/Hour of Sleep)
Secondary outcome measures
Arousal Index (AI, Events/Hours of Sleep)
Nadir oxygen saturation during sleep (LSpO2, %)
RescOSA Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Interventional armActive Control3 Interventions
This is a two arm study. Patients will receive only one of the following drugs based on their altered sleep apnea trait. Patients with decreased arousal threshold will undergo treatment with placebo or Trazodone 100 mg in random order (one pill before 30 minutes before bedtime), patients with decreased pharyngeal muscle responsiveness will undergo treatment with placebo or Atomoxetine 80 mg + Eszopiclone 3 mg in random order (one pill before 30 minutes before bedtime), patients with increased loop gain will undergo treatment with placebo or Acetazolamide 500 mg in random order (one pill before 30 minutes before bedtime).
Group II: PlaceboPlacebo Group1 Intervention
This is a two arm study. Patients will receive only one of the following drugs based on their altered sleep apnea trait. Patients with decreased arousal threshold will undergo treatment with placebo or Trazodone 100 mg in random order (one pill before 30 minutes before bedtime), patients with decreased pharyngeal muscle responsiveness will undergo treatment with placebo or Atomoxetine 80 mg + Eszopiclone 3 mg in random order (one pill before 30 minutes before bedtime), patients with increased loop gain will undergo treatment with placebo or Acetazolamide 500 mg in random order (one pill before 30 minutes before bedtime).
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,807 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unstable major health conditions.I do not have heart, liver, kidney issues, glaucoma, priapism, and I'm not pregnant/breastfeeding or have mental health issues that trazodone could worsen.I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.I am currently taking antidepressants.I do not have conditions like severe liver disease, kidney issues, or allergies to certain medications that would prevent me from taking acetazolamide.I am not taking any medications that affect my breathing.I have a breathing or lung disorder other than obstructive sleep apnea.I do not have any health conditions that would make atomoxetine unsafe for me.I do not have allergies to eszopiclone, COPD, am not pregnant or breastfeeding, and do not have liver disease.My sleep apnea treatment with a device hasn't reduced my symptoms enough.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Interventional arm
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.
Are there any available openings for people who want to participate in this clinical trial?
"Unfortunately, this study is not looking for new participants at the moment. However, there are many other medical trials that patients can enroll in. This specific study was posted on September 1st, 2022 and was last updated on July 18th, 2022."
Answered by AI
Does this controlled experiment have an age limit for participants?
"In order for a patient to be included in this trial, they must fall between the ages of 21 and 70. Out of the 40 trials available for patients under 18, and the 203 trials offered to people over 65, this is one specific study."
Answered by AI
What are the requirements for someone to be eligible for this clinical trial?
"This study is looking for 70 individuals who have obstructive sleep apnea and are between 21 and 70 years old. Most importantly, potential patients should have tried other therapies like MAD or HGNS with little success, as indicated by a residual AHI of ≥ 15 events/hr."
Answered by AI
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