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N/A N=40 Randomized Treatment

Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Ischemic Stroke · Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT01703663 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Apnea-hypopnea Index — 17.1; 25.2 apneas plus hypopneas per hour — p=0.183

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
EPAP (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Apr 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Apnea-hypopnea Index		 17.1; 25.2 0.183

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • adults with an ischemic stroke (including TIA with infarction) within the prior 14 days

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01703663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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