NCT00108498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2007

First QC Date

April 15, 2005

Last Update Submit

January 20, 2009

Conditions

Obstructive Sleep Apnea

Keywords

sleep apneamirtazapinesleep

Outcome Measures

Primary Outcomes (3)

  • The apnea + hypopnea index (AHI)

  • Sleep quality

  • The degree of arterial oxygen desaturation

Interventions

mirtazapineDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known OSA mild to moderate

You may not qualify if:

  • On antidepressant or antipsychotic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malcom Randall VAMC

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2005

First Posted

April 18, 2005

Study Start

October 1, 2003

Study Completion

March 1, 2007

Last Updated

January 21, 2009

Record last verified: 2007-05

Locations

US(1)