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Clinical Trials/NCT00108498
NCT00108498
Completed
Phase 1

New Pharmacological Treatment for Obstructive Sleep Apnea

US Department of Veterans Affairs1 site in 1 countryOctober 2003

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
US Department of Veterans Affairs
Locations
1
Primary Endpoint
The apnea + hypopnea index (AHI)
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
March 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Known OSA mild to moderate

Exclusion Criteria

  • On antidepressant or antipsychotic medications

Outcomes

Primary Outcomes

The apnea + hypopnea index (AHI)

Sleep quality

The degree of arterial oxygen desaturation

Study Sites (1)

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