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

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ClinicalTrials.gov Identifier: NCT02699138
Recruitment Status : Suspended (Research fellow left institution)
First Posted : March 4, 2016
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders Drug: Trazodone Drug: Placebo Device: Epiglottic catheter Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trazodone
To determine effect of trazodone on quality of sleep as measured by apnea hypopnea index in subjects with obstructive sleep apnea and PTSD on routine overnight polysomnogram.
Drug: Trazodone
100mg of trazodone to be administered orally once.

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.

Placebo Comparator: Placebo
To compare placebo outcomes against administration of trazodone
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.




Primary Outcome Measures :
  1. Respiratory arousal threshold [ Time Frame: 8 hours ]
    Arousal threshold will be measured by epiglottic catheter placement during routine polysomnograph. Respiratory arousal threshold is measured by standard criteria and determined by difference in the terminal pressure measured prior to cortical arousal on EEG and the baseline epiglottic pressure.

  2. Apnea hypopnea index [ Time Frame: 8 hours ]
    Severity of obstructive sleep apnea measured by the apnea hypopnea index. Measured by standard sleep scoring criteria.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal sleep study aside from elevated AHI
  • Prior home sleep test (HST) or polysomnogram with results consistent with mild, moderate, or severe sleep apnea. If a sleep study has not been performed in the past, the participant will be offered an HST and included if OSA is confirmed on HST.
  • PTSD as diagnosed by psychiatrist, psychologist, or other licensed mental health professional

Exclusion Criteria:

  • Any known cardiac (apart from treated hypertension), symptomatic pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
  • Pregnant women.
  • History of hypersensitivity to Afrin, Lidocaine, or Trazodone
  • History of bleeding diathesis and/or gastrointestinal bleeding.
  • Daily use of any sedative medications that may affect sleep or breathing, including benzodiazepines, opioids, or hypnotics.
  • A psychiatric disorder, other than mild depression or PTSD; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
  • Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.
  • More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
  • Subjects with oxyhemoglobin desaturations to <70% on the initial PSG (Aim 1) will be excluded from participation in Aim 2.
  • Current, everyday use of continuous positive airway pressure therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699138


Locations
United States, California
University of California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Robert Owens, MD UCSD

Responsible Party: Robert L. Owens, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02699138     History of Changes
Other Study ID Numbers: UCSD151424
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents