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...
Date First Received: April 15, 2005
Last Updated: May 15, 2007
Verified by: Department of Veterans Affairs, May 2007
Clinical Trial Phase: Phase 1 | Start Date: October 2003
Overall Status: Completed
Brief Summary
Official Title: “New Pharmacological Treatment for Obstructive Sleep Apnea”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: mirtazapine
Outcome Measures for this Clinical Trial
Primary Measures
- The apnea + hypopnea index (AHI)
- Sleep quality
- The degree of arterial oxygen desaturation
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Known OSA mild to moderate
Exclusion Criteria:
- On antidepressant or antipsychotic medications
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Department of Veterans Affairs
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00108498
Study ID Number: RESP-011-02F
ClinicalTrials.gov Identifier: NCT00108498
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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