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NCT00108498 · ClinicalTrials.gov registry record · Phase 1

New Pharmacological Treatment for Obstructive Sleep Apnea

A Phase 1 study of Obstructive Sleep Apnea, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 1
Development phase
1
Study location

NCT00108498: Completed Phase 1 study of Obstructive Sleep Apnea, sponsored by US Department of Veterans Affairs.

NCT00108498 is a Phase 1 study of Obstructive Sleep Apnea that has completed, run by US Department of Veterans Affairs. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00108498, a Phase 1 study of Obstructive Sleep Apnea, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 1
Development phase
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG mirtazapine

Study Locations (1)

Florida

  • Malcom Randall VAMC - Gainesville

Trial Details

FieldValue
Start Date 2003-10
Est. Completion 2007-03
Phase Phase 1
US Department of Veterans Affairs

632 total trials

What the finished NCT00108498 record still lists

NCT00108498 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which mirtazapine is the first listed.

NCT00108498 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00108498 about?

NCT00108498 is a clinical study titled "New Pharmacological Treatment for Obstructive Sleep Apnea". 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 o...

What is the current status of trial NCT00108498?

This trial is currently completed. It is a Phase 1 study. The study started on 2003-10. Estimated completion is 2007-03.

What conditions does trial NCT00108498 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea.

What interventions are being tested in trial NCT00108498?

The interventions under investigation include: mirtazapine (DRUG).

Who is sponsoring clinical trial NCT00108498?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00108498 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00108498, the US trial registry maintained by the National Library of Medicine. NCT00108498 (unsized enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.