IRCT20220201053905N1
Recruiting
Phase 3
Evaluating the effect of Atomoxetine and Oxybutynin combination on the number of apnea in obstructive sleep apnea patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea.
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •established OSA diagnosis in the past medical history with AHI more than 20 in the last polysomnography(if accessible)
- •age between 21 and 65 years old
- •noncompliant for CPAP or BiPAP
- •not indicated for surgical treatment, according to the sleep specialist. or the situation that the patient doesn't tend to surgical treatment
Exclusion Criteria
- •the existence of any other disorders(except controlled HTN, Hyperlipidemia and Diabetes)
- •the consumption of any drug resulting in changes in ventilation physiology, sleep/awake cycle and the muscles; such as methocarbamol, tramadol, TCAs, SSRIs, SNRIs, ventilation stimulants and depressants, hypnotics, CNS stimulants, central sleep apnea, and etc.
- •Claustrophobia
- •Inability for being in supine position
- •Allergy to any of lidocaine, atomoxetine, oxybutynin, vitamin C
- •the existence of any underlying heart diseases such as arrhythmias
- •the consumption of psychiatric drugs such as atomoxetine or any other drug that is prescribed for medical care and could not be withdrawn while the experiment night.
- •for women: pregnancy
- •the history of seizure, panic disorder, hyperventilation syndrome, ADHD, ASD
- •Any disease that exacerbates by antimuscarinic drugs such as urinary retention, BPH, severe ulcerative colitis, glaucoma, myasthenia gravis
Outcomes
Primary Outcomes
Not specified
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