Actively Recruiting
Rescue Pharmacotherapy for OSA
Led by Brigham and Women's Hospital · Updated on 2024-06-04
70
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.
CONDITIONS
Official Title
Rescue Pharmacotherapy for OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 70 years
- Individuals who have failed mandibular advancement device or hypoglossal nerve stimulation therapy, defined as a residual Apnea Hypopnea Index (AHI) of 15 or more events per hour on these therapies
You will not qualify if you...
- Sleep breathing or respiratory disorders other than obstructive sleep apnea, including central sleep apnea (>50% central respiratory events) or chronic hypoventilation/hypoxemia (awake oxygen saturation < 92%) due to chronic obstructive pulmonary disease or other conditions
- Other sleep disorders such as periodic limb movements (index > 20/hr), narcolepsy, or parasomnias
- Any unstable major medical condition
- Use of medications that stimulate or depress breathing, including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, or 4-hydroxybutanoic acid
- Use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
- Contraindications for atomoxetine, including pheochromocytoma, use of monoamine oxidase inhibitors, benign prostatic hypertrophy, urinary retention, untreated narrow angle glaucoma, bipolar disorder, mania, psychosis, significant constipation or gastric retention, seizure disorders, significant kidney, liver, or cardiovascular conditions, severe hypertension, cardiomyopathy or heart failure, advanced atherosclerosis, history of cerebrovascular events, cardiac arrhythmias, serious cardiac conditions, myasthenia gravis, pregnancy or breastfeeding
- Contraindications for eszopiclone, including hypersensitivity, chronic obstructive pulmonary disease, pregnancy, breastfeeding, or liver disease
- Contraindications for acetazolamide, including hyperchloremic acidosis, hypokalemia, hyponatremia, adrenal insufficiency, impaired kidney function, hypersensitivity, or marked liver disease
- Contraindications for trazodone, including suicidal ideation, bipolar disorder, use of monoamine oxidase inhibitors, coronary artery disease, cardiac arrhythmias, QT prolongation, hepatic disease, renal failure, closed angle glaucoma, priapism, or pregnancy/breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
D
David Andrew Wellman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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