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

Evaluating the effect of timing of administration of the drugs atomoxetine and trazodone in divided doses on the number of apneic episodes and sleep indexes in obstructive sleep apnea patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240706062343N1

Enrollment

Registered

2024-08-05

Start date

2024-09-22

Completion date

Unknown

Last updated

2024-08-26

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: Two 40 milligram atomoxetine tablets at 6 pm, plus one 50 milligram trazodone tablet 30 minutes before bed. Intervention 2: Control group: Two placebo tablets resem

Eligibility

Sex/Gender

All

Age

21 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number 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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParsa Mirzayi

Tehran University of Medical Sciences

p-Mirzayi@student.tums.ac.ir+98 21 6119 2053

Outcome results

None listed

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