New Pharmacological Treatment for Obstructive Sleep Apnea

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 1

Conditions: Obstructive Sleep Apnea

Treatments: Drug: mirtazapine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00108498

RESP-011-02F

Details and patient eligibility

About

This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known OSA mild to moderate

Exclusion criteria

• On antidepressant or antipsychotic medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind