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New Pharmacological Treatment for Obstructive Sleep Apnea

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: April 15, 2005
Last updated: January 20, 2009
Last verified: May 2007
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.

Condition Intervention Phase
Obstructive Sleep Apnea Drug: mirtazapine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: New Pharmacological Treatment for Obstructive Sleep Apnea

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • The apnea + hypopnea index (AHI)
  • Sleep quality
  • The degree of arterial oxygen desaturation

Study Start Date: October 2003
Estimated Study Completion Date: March 2007

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known OSA mild to moderate

Exclusion Criteria:

  • On antidepressant or antipsychotic medications
  Contacts and Locations
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Please refer to this study by its identifier: NCT00108498

United States, Florida
Malcom Randall VAMC
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
  More Information Identifier: NCT00108498     History of Changes
Other Study ID Numbers: RESP-011-02F
Study First Received: April 15, 2005
Last Updated: January 20, 2009

Keywords provided by VA Office of Research and Development:
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents processed this record on September 21, 2017