Evaluating the effect of Atomoxetine and Oxybutynin combination on the number of apnea in obstructive sleep apnea patients referring to the sleep clinics of Tehran University of Medical Sciences

Phase 3

Recruiting

• Conditions: Obstructive Sleep Apnea.; Obstructive sleep apnea (adult) (pediatric); G47.33

• Registration Number: IRCT20220201053905N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

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of psychiatric drugs such as atomoxetine or any other drug that is prescribed for medical care and could not be withdrawn while the experiment night.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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AHI(Apnea-Hypopnea index): Number of apnea plus hypopnea during a night sleep per hour. Timepoint: Just after intervention. Method of measurement: Polysomnography records.