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?Effects of Atomoxetine and Trazodone combination in obstructive sleep apnea

Phase 2
Conditions
obstructive sleep apnea.
Obstructive sleep apnea (adult) (pediatric)
G47.33
Registration Number
IRCT20220607055095N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
18
Inclusion Criteria

Definite diagnosis of obstructive sleep apnea in medical history 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

commodities' existence (excluding controlled blood pressure, hyperlipidemia and diabetes)
any underlying cardiac disease, such as arrhythmia that is seen on the ECG
History of seizures, Panic disorder, Hyperventilation syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
Hypersensitivity to lidocaine, atomoxetine or trazodone, substances used in placebo
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
Inability to sleep in supine position
Pregnancy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Apnea-hypopnea index. Timepoint: medication Night. Method of measurement: Polysomnography.
Secondary Outcome Measures
NameTimeMethod
Safety. Timepoint: The morning after taking the drug. Method of measurement: asking the patient.
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