Serotonin and the Upper Airway in Obstructive Sleep Apnea

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00100464

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. The medications being studied are paroxetine, a commonly used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary supplement without a prescription. Because the effects of paroxetine in previous studies were not very large, we will also study it combined with 5HTP to see if the effect on the upper airway muscles is greater.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: Paroxetine Drug: 5HTP	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Serotonin and the Upper Airway in Obstructive Sleep Apnea

Study Start Date :

Nov 1, 2000

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Group A: 20 Adult patients with mild to severe sleep apnea. If patients are being treated with nasal CPAP, they will continue treatment except on study nights.

Group B: 20 normal adult non-snoring subjects.