Effect of combination treatment of atomoxetine and oxybutyni
- Conditions
- Obstructive sleep apneaOSA AHI
- Registration Number
- JPRN-jRCTs031200046
- Lead Sponsor
- Sakao Seiichiro
- Brief Summary
Contrary to previous reports, ATO and OXY combined therapy did not significantly improve AHI in Japanese OSA. Sleep architecture showed significant changes, which could be attributed to differences in the metabolic capacity of Asians for ATO.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
1. Patients diagnosed with OSA who have a treatment history or are undergoing treatment for OSA
2. Patients aged between 20 and 70 years
3. Written informed consent
1. Patients with central apnea superior to obstructive apnea
2. Patients with drug allergy to atomoxetine and oxybutynin
3. Patients with severe liver function, cardiac function, renal function, pulmonary function disorder
4. Patients with severe central nervous system disease
5. Patients with bipolar disorder or psychotic disorder
6. Patients who have already taken MAO inhibitors or drugs equivalent to atomoxetine or oxybutynin
7. Pregnant women
8. Lactating women
9. Patients who are difficult to keep supine position during sleep
10. Patients who have a history of angle-closure glaucoma, history of paralytic ileus, history of pheochromocytoma, history of benign prostatic hyperplasia, history of urinary retention, history of myasthenia gravis
11. Patients with severe hyperthyroidism, ulcerative colitis, tachyarrhythmia, prolonged QT syndrome, seizures, cerebrovascular disorder
12. Patients judged to be ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in average value of AHI
- Secondary Outcome Measures
Name Time Method SpO2 minimum difference, SpO2 drop time difference, Differences in sleeping stage