Serotonin and the Upper Airway in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Serotonin and the Upper Airway in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100464
• Other study ID #: RESP-013-98F
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2004
• Last updated: September 16, 2013
• Start date: November 2000
• Est. completion date: December 2003

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Paroxetine

• 5HTP

Locations

Country	Name	City	State
United States	Malcolm Randall VA Medical Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,