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New Pharmacological Treatment for Obstructive Sleep Apnea
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108498
  Purpose

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 I

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Mirtazapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: New Pharmacological Treatment for Obstructive Sleep Apnea

Further study details as provided by Department of Veterans Affairs:

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known OSA mild to moderate

Exclusion Criteria:

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

Locations
United States, Florida
Malcom Randall VAMC
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
  More Information

Study ID Numbers: RESP-011-02F
Study First Received: April 15, 2005
Last Updated: May 15, 2007
ClinicalTrials.gov Identifier: NCT00108498  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
sleep apnea
mirtazapine
sleep

Study placed in the following topic categories:
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias
Mirtazapine
Sleep Disorders, Intrinsic
Histamine
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Histamine phosphate

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Histamine Agents
Adrenergic alpha-Antagonists
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Histamine Antagonists
Therapeutic Uses
Histamine H1 Antagonists
Adrenergic Antagonists
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009