Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Completed · Not applicable
Conditions studied: Ischemic Stroke, Obstructive Sleep Apnea
In brief
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke. Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night. Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.
Key facts
- Study ID
- NCT01703663
- Run by
- University of Michigan
- People needed
- 40
- Starts
- 2012-11-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults with an ischemic stroke (including TIA with infarction) within the prior 14 days
You may not qualify if…
- Current use of any transnasal tube (eg dobhoff tube)
- Current use of CPAP, mechanical ventilation, or supplemental oxygen
- Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
- Severe heart disease (including severe heart failure)
- Pathologically low blood pressure
- An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
- Sores, abrasions, or skin or mucosal irritation on or around the nose.
- Known pregnancy
- Inability to provide informed consent
- Use of alpha blockers or short acting nitrates
- Permanent pacemaker
- Sustained non-sinus cardiac arrhythmia
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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