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study of medium term effects of Trazodone and Atomoxetine combination in obstructive sleep apnea

pilot study of medium term effects of Trazodone and Atomoxetine combination on the number of apnea and apnea-hypopnea sleep index in obstructive sleep apnea patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220607055095N2
Enrollment
18
Registered
2023-07-19
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

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 group: All patients are treated with a combination of atomoxetine and trazodone for one month, and then undergo polysomnography..

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: Definite diagnosis of obstructive sleep apnea with AHI>15 in polysomnography lack of compliance treatment with CPAP or BIPAP either the patient is unwilling to have surgery or they are not candidates for surgery in the opinion of the expert

Exclusion criteria

Exclusion criteria: commodities' existence (excluding controlled blood pressure, hyperlipidemia and diabetes) Taking any medication that leads to changes in the physiology of breathing, sleep / wake and muscles Taking any medication that leads to changes in the physiology of breathing, sleeping / waking and muscles any underlying cardiac disease, such as arrhythmia Inability to sleep in supine position Hypersensitivity to lidocaine, atomoxetine or trazodone Pregnancy History of seizures, Panic disorder, Hyperventilation syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder any hepatic disease or failure

Design outcomes

Primary

MeasureTime frame
Apnea-hypopnea index. Timepoint: after on month medication consumption. Method of measurement: Polysomnography.

Secondary

MeasureTime frame
Minimum O2 saturation. Timepoint: once. Method of measurement: pulse oxymetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezu Najafi

Tehran University of Medical Sciences

najafeeaz.inbox@gmail.com+98 21 5546 0184

Outcome results

None listed

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