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

Evaluating the effect of Atomoxetine and Oxybutynin combination on the number of apnea in obstructive sleep apnea patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220201053905N1

Enrollment

Registered

2022-06-08

Start date

2022-04-04

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea. Obstructive sleep apnea (adult) (pediatric)

Interventions

Intervention 1: Intervention group: This group will consume Oxybutynin-Atomoxetine combination during the first night of study, then they would consume placebo(Vitamin C) at least 1 weak later. Interv

Eligibility

Sex/Gender

All

Age

21 Years to 65 Years

Inclusion 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

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of psychiatric drugs such as atomoxetine or any other drug that is prescribed for medical care and could not be withdrawn while the experiment night.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

Design outcomes

Primary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed AmiriFard

Tehran University of Medical Sciences

dr.amirifard@gmail.com+98 21 6119 2398

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026