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New Pharmacological Treatment for Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00108498
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: mirtazapine Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: New Pharmacological Treatment for Obstructive Sleep Apnea
Study Start Date : October 2003
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Mirtazapine

Primary Outcome Measures :
  1. The apnea + hypopnea index (AHI)
  2. Sleep quality
  3. The degree of arterial oxygen desaturation

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Known OSA mild to moderate

Exclusion Criteria:

  • On antidepressant or antipsychotic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108498

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United States, Florida
Malcom Randall VAMC
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
US Department of Veterans Affairs
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ClinicalTrials.gov Identifier: NCT00108498    
Other Study ID Numbers: RESP-011-02F
First Posted: April 18, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: May 2007
Keywords provided by VA Office of Research and Development:
sleep apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists