?valuating the timing of administration of atomoxetine and trazodone on obstructive sleep apnea

Phase 3

Conditions: Obstructive sleep apnea.
Obstructive sleep apnea (adult) (pediatric)
G47.33

Registration Number: IRCT20240706062343N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 18

Inclusion Criteria

Patients with a diagnosis of obstructive sleep apnea in medical records with AHI=20 in latest polysomnography (if performed)
Patients who are not candidates for or aren't compliant with standard obstructive sleep apnea treatments

Exclusion Criteria

Presence of other diseases (except for controlled hypertension, hyperlipidemia, diabetes)
Usage of any drug that interferes with respiratory physiology, sleep/wake and muscles, including methocarbamol, tramadol, TCAs, SSRIs, SNRIs, respiratory stimulants of depressants, hypnotics, central nervous system stimulants, central sleep apnea, etc
Claustrophobia
Hypersensitivity to lidocaine, atomoxetine or trazodone
Presence of underlying cardiac disease including arrhythmia
Usage of psychiatric drugs (including atomoxetine) or any drug that is required for medical treatment and cannot be skipped on the night of the study
In females: pregnancy
History of seizure, panic disorder, hyperventilation syndrome, attention deficient hyperactivity disorder, autism spectrum disorder

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of apnea episodes. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.;Apnea-Hypopnea Index. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.

Secondary Outcome Measures

Name	Time	Method
Apnea Index. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.;Hypopnea Index. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.;Minimum arterial oxygen. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.;Mean arterial oxygen. Timepoint: Two nights one week apart. Method of measurement: Polysomnography.