Trazodone Dose Tolerance and APAP Adherence

• Status: Suspended
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louis Stokes VA Medical Center
• Treatments: Trazodone

Criteria

Inclusion Criteria:

• Louis Stokes Cleveland VA Sleep Medicine clinic patient

• AHI greater than or equal to 5

• obstructive sleep apnea

• new initiation or nonadherence to APAP

Exclusion Criteria:

• 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