Status:
RECRUITING
Rescue Pharmacotherapy for OSA
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
Exclusion
- 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 oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
- 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.
- Contraindications for atomoxetine, including:
- 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
- Contraindications for eszopiclone, including:
- Hypersensitivity to eszopiclone
- Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- Breast feeding
- Liver disease
- Contraindications for acetazolamide, including:
- 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.
- Contraindications for trazodone, including:
- 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
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05293600
Start Date
July 1 2023
End Date
October 30 2026
Last Update
June 4 2024
Active Locations (1)
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1
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115