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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Ischemic Stroke
• Interventions: Device: EPAP

• Registration Number: NCT01703663
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-10
• Study Start: 2012-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-05-19
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-19
• Last Update Submitted: 2016-08-19
• Results First Posted: 2016-10-13
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

1. Current use of any transnasal tube (eg dobhoff tube)
2. Current use of CPAP, mechanical ventilation, or supplemental oxygen
3. Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
4. Severe heart disease (including severe heart failure)
5. Pathologically low blood pressure
6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
7. Sores, abrasions, or skin or mucosal irritation on or around the nose.
8. Known pregnancy
9. Inability to provide informed consent
10. Use of alpha blockers or short acting nitrates
11. Permanent pacemaker
12. Sustained non-sinus cardiac arrhythmia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EPAP	EPAP	Provent Sleep Apnea Therapy.

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea Index	night 1 and night 2	Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States