New Pharmacological Treatment for Obstructive Sleep Apnea

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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...

Brief Summary

Official Title: “New Pharmacological Treatment for Obstructive Sleep Apnea”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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 Investigator Information

Lead Investigator: Department of Veterans Affairs U.S. Fed

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00108498