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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703663
• Other study ID #: U037625
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2012
• Last updated: May 26, 2015
• Start date: November 2012
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Michigan IRBMED.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Ischemic Stroke
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

Intervention

Device:
• EPAP

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index		night 1 and night 2	No