N/A Completed N=40 Randomized Treatment

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

Stroke · Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT01703663 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcomePrimary: Apnea-hypopnea Index — 17.1; 25.2 apneas plus hypopneas per hour — p=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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Apnea-hypopnea Index	17.1; 25.2	0.183

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. Informational only — not medical advice.