Clinical trial for Obstructive Sleep Apnea
Official title Rescue Pharmacotherapy for OSA
ClinicalTrials.gov ID: NCT05293600
What this study is testing
What is Acetazolamide?
An investigational oral medication being studied for treating obstructive sleep apnea in patients with high loop gain. It is designed to reduce the sensitivity of the respiratory control system to changes in blood gases.
Also referred to as Acetazolamide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding a specific medication can improve sleep apnea in patients who do not fully respond to a mandibular advancement device or hypoglossal nerve stimulation.
- Who it's for
- Adults with obstructive sleep apnea who are not fully helped by a jaw‑advancing device or nerve‑stimulation therapy.
- What's involved
- Participants will receive one of three drugs, acetazolamide, atomoxetine plus eszopiclone, or trazodone, chosen based on their sleep‑apnea characteristics, and will have regular medical visits and sleep tests.
- Time commitment
- The study lasts several months, with multiple clinic visits and sleep studies scheduled throughout the trial.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70
You may be able to join if
- Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
You likely can't join if
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (\>50% of respiratory events scored as...
- Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
- Any unstable major medical condition.
- Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline...
- Use of SSRIs/SNRIs.
- pheochromocytoma
See the full eligibility criteria
- Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by...
- Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
- Any unstable major medical condition.
- Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of SSRIs/SNRIs.
- pheochromocytoma
- use of monoamine oxidase inhibitors
- benign prostatic hypertrophy, urinary retention
- untreated narrow angle glaucoma
- bipolar disorder, mania, psychosis
- clinically significant constipation, gastric retention
- pre-existing seizure disorders
- clinically-significant kidney disorders
- clinically-significant liver disorders
- clinically-significant cardiovascular conditions
- severe hypertension (SBP\>180 mmHg or DBP\>110 mmHg measured at baseline)
- cardiomyopathy (LVEF\<50%) or heart failure
- advanced atherosclerosi
- history of cerebrovascular events
- history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
- other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
- myasthenia gravis
- pregnancy/breast-feeding
- Hypersensitivity to eszopiclone
- Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- Breast feeding
- Liver disease
- Hyperchloremic acidosis
- Hypokalemia
- Hyponatremia
- Adrenal insufficiency
- Impaired kidney function
- Hypersensitivity to acetazolamide or other sulfonamides.
- Marked liver disease or impairment of liver function, including cirrhosis.
- suicidal ideation
- bipolar disorder, mania
- use of monoamine oxidase inhibitors
- coronary artery disease
- cardiac arrhythmias
- QT prolongation
- hepatic disease
- renal failure or impairment
- closed angle glaucoma
- priapism
- pregnancy/breast-feeding
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.