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

Phase 2
Recruiting
Conditions
obstructive sleep apnea.
Obstructive sleep apnea (adult) (pediatric)
G47.33
Registration Number
IRCT20220607055095N2
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
18
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Apnea-hypopnea index. Timepoint: after on month medication consumption. Method of measurement: Polysomnography.
Secondary Outcome Measures
NameTimeMethod
Minimum O2 saturation. Timepoint: once. Method of measurement: pulse oxymetry.
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