Serotonin and the Upper Airway in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00100464
First received: December 30, 2004
Last updated: September 16, 2013
Last verified: September 2013
  Purpose
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 Intervention Phase
Obstructive Sleep Apnea
Drug: Paroxetine
Drug: 5HTP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Serotonin and the Upper Airway in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Study Start Date: November 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100464

Locations
United States, Florida
Malcolm Randall VA Medical Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
  More Information

ClinicalTrials.gov Identifier: NCT00100464     History of Changes
Other Study ID Numbers: RESP-013-98F 
Study First Received: December 30, 2004
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Serotonin
Sleep Apnea Syndrome
Pharyngeal Muscles

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Paroxetine
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on August 23, 2016