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Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder

NCT02699138 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-07-10

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper airway. However, it is increasingly recognized that multiple additional non-anatomical mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic stress disorder (PTSD) than in those without PTSD have been reported however the mechanism behind this increased prevalence has not been investigated. Our hypothesis is that patients with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up too easily) than patients without PTSD. The goal of this project will be to study and compare the ArTH in patients with PTSD and those without. In addition, we plan to see whether medications can be used to increase the arousal threshold and treat OSA in patients with PTSD.

Conditions

  • Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders

Interventions

DRUG

Trazodone

100mg of trazodone to be administered orally once.

DRUG

Placebo

Compounded sugar pill

DEVICE

Epiglottic catheter

Catheter that can be placed through the nose to a position behind the tongue to monitor for upper airway obstruction and to measure changes in pressure below the obstruction.

Sponsors & Collaborators

Principal Investigators

  • Robert Owens, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699138 on ClinicalTrials.gov