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

Withdrawn before enrolling · Early Phase 1 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders

In brief

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.

Key facts

Study ID

NCT02699138

Run by

University of California, San Diego

People needed

0

Starts

2021-10-01

Expected to finish

2022-12-01

Last updated by the study team

2019-07-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• University of California San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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