Effect of combination treatment of atomoxetine and oxybutynin

JRCT ID: jRCTs031200046

Registered date:06/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obstructive sleep apnea
• Date of first enrollment: 06/06/2020
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Take atomoxetine and oxybutynin 30 minutes before falling asleep and perform PSG test

Outcome(s)

• Primary Outcome: Difference in average value of AHI
• Secondary Outcome: SpO2 minimum difference, SpO2 drop time difference, Differences in sleeping stage

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Sakao Seiichiro
• Source(s) of Monetary Support: Chiba university hospital advanced medical development expenses