New Pharmacological Treatment for Obstructive Sleep Apnea

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00108498

Enrollment

Unknown

Registered

2005-04-18

Start date

2003-10-31

Completion date

2007-03-31

Last updated

2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, mirtazapine, sleep

Brief summary

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.

Interventions

DRUGmirtazapine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Known OSA mild to moderate

Exclusion criteria

* On antidepressant or antipsychotic medications

Design outcomes

Primary

Measure	Time frame
The apnea + hypopnea index (AHI)	—
Sleep quality	—
The degree of arterial oxygen desaturation	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026