Back to resultsNew Pharmacological Treatment for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mirtazapine
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, mirtazapine, sleep
Eligibility Criteria
Inclusion Criteria: Known OSA mild to moderate Exclusion Criteria: On antidepressant or antipsychotic medications
Sites / Locations
- Malcom Randall VAMC
Outcomes
Primary Outcome Measures
The apnea + hypopnea index (AHI)
Sleep quality
The degree of arterial oxygen desaturation
Secondary Outcome Measures
Full Information
NCT ID
NCT00108498
First Posted
April 15, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00108498
Brief Title
New Pharmacological Treatment for Obstructive Sleep Apnea
Official Title
New Pharmacological Treatment for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, mirtazapine, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Primary Outcome Measure Information:
Title
The apnea + hypopnea index (AHI)
Title
Sleep quality
Title
The degree of arterial oxygen desaturation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known OSA mild to moderate
Exclusion Criteria:
On antidepressant or antipsychotic medications
Facility Information:
Facility Name
Malcom Randall VAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
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New Pharmacological Treatment for Obstructive Sleep Apnea
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