Drug treatment for patients with obstructive sleep apnea who didn't respond to other therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of adding pharmacotherapy to patients with obstructive sleep apnea (OSA) who have not responded to mandibular advancement devices (MAD) or hypoglossal nerve stimulation (HGNS). Participants will receive one of several drug treatments, including acetazolamide, trazodone, or a combination of atomoxetine and eszopiclone, based on their specific OSA endotype. The goal is to identify effective rescue strategies for those who continue to experience symptoms despite existing therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.

Exclusion Criteria:

* 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

Where it's running

• Sleep Disorders Research Program Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: David Andrew Wellman, MD
• Email: awellman@bwh.harvard.edu
• Phone: 5089827401

Similar studies

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• CES-EES score and a wearable ring for diagnosing obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.