Trazodone Dose Tolerance and APAP Adherence

Paused · Phase 1 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive

In brief

Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not adherent to it. Participants will be randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for 14 days. The investigators will monitor side-effects and adherence to positive airway pressure therapy.

Key facts

Study ID

NCT02945644

Run by

Louis Stokes VA Medical Center

People needed

45

Starts

2017-02-13

Expected to finish

2020-12-01

Last updated by the study team

2020-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Louis Stokes Cleveland VA Sleep Medicine clinic patient
• AHI greater than or equal to 5
• obstructive sleep apnea
• new initiation or nonadherence to APAP

You may not qualify if…

• schizophrenia
• bipolar disorder
• current use of trazodone or sedative hypnotics
• allergy to trazodone
• current use of tricyclic antidepressants or monoamine oxidase inhibitors
• current alcohol or drug abuse
• heart failure
• heart attack in past 3 months
• congenital long QT, ventricular arrhythmia (including Torsades de Pointes), bradycardia, or digoxin therapy
• use of amiodarone, sotalol, dofetilide, or dronedarone
• epilepsy
• liver disease
• pregnancy (or planning pregnancy)
• right of priapism: history of priapism, sickle cell disease, Farby disease

Where it is running

• Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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