Identifying patients with sleep apnea who respond to specific therapy
Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy
PHASE1; PHASE2 · Brigham and Women's Hospital · NCT05550246
This study is testing a new combination treatment for obstructive sleep apnea to see which patients might benefit the most from it based on their individual sleep characteristics.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05550246 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a combination therapy using atomoxetine and oxybutynin for patients with obstructive sleep apnea (OSA). The researchers aim to identify which patients are likely to benefit from this treatment based on their individual pathophysiological traits assessed through advanced sleep studies. By classifying patients as predicted responders or nonresponders, the study seeks to enhance treatment efficacy and tailor interventions more effectively. The study will also explore specific traits that may predict better outcomes, such as upper airway collapsibility and muscle compensation.
Who should consider this trial
Good fit: Ideal candidates include individuals with suspected or diagnosed obstructive sleep apnea who have recent drug-induced sleep endoscopy results.
Not a fit: Patients with uncontrolled medical conditions or those currently using medications that affect respiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promise in tailoring treatments based on patient-specific traits, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected or diagnosed OSA * Recent drug induced sleep endoscopy results available (performed as part of routine clinical care). Exclusion Criteria: * Any uncontrolled medical condition * Current use of the medications under investigation * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid). * Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines). * Current use of SNRIs/SSRIs or anticholinergic medications. * Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition. * Respiratory disorders other than sleep disordered breathing: chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * Other sleep disorders: periodic limb movements, narcolepsy, or parasomnias. * Contraindications for atomoxetine and oxybutynin, including: * hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria) * pheochromocytoma * use of monoamine oxidase inhibitors * benign prostatic hypertrophy, urinary retention * untreated narrow angle glaucoma * bipolar disorder, mania, psychosis * history of major depressive disorder (age\<24). * history of attempted suicide or suicidal ideation within one year prior to screening * clinically significant constipation, gastric retention * pre-existing seizure disorders * clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2) * clinically-significant liver disorders * clinically-significant cardiovascular conditions * moderate-to-severe hypertension (SBP\>180 mmHg or DBP\>110 mmHg measured at baseline; average of evening and morning measures\*) * cardiomyopathy (LVEF\<50%) or heart failure * advanced atherosclerosis * 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 * Claustrophobia * Pregnancy or nursing n.b. Development of new hypertension that is recognized on the final day of study medications during outcomes collection will not be used as stopping criteria for discontinuing outcomes collection. Participants that are sexually active and able to become pregnant must agree to use birth control for the entire study.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Scott A Sands, PhD — Brigham and Women's Hospital
- Study coordinator: Scott A Sands, PhD
- Email: sasands@bwh.harvard.edu
- Phone: 617-278-0911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea