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

NCT02699138 | Withdrawn Early Phase 1 FDA Device

• 1 other identifier: UCSD151424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders

Outcome Measures

Primary Outcomes (2)

• Respiratory arousal threshold

  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.

  8 hours

• Apnea hypopnea index

  Severity of obstructive sleep apnea measured by the apnea hypopnea index. Measured by standard sleep scoring criteria.

  8 hours

Study Arms (2)

Trazodone

EXPERIMENTAL

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; Device: Epiglottic catheter

Placebo

PLACEBO COMPARATOR

To compare placebo outcomes against administration of trazodone

Drug: Placebo; Device: Epiglottic catheter

Interventions

Trazodone DRUG

100mg of trazodone to be administered orally once.

Trazodone

Placebo DRUG

Compounded sugar pill

Placebo

Epiglottic catheter DEVICE

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; Trazodone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stress Disorders, Post-Traumatic

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Robert Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 4, 2016
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

US (1)