Back to resultsNasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Primary Purpose
Ischemic Stroke, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EPAP
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Sleep Apnea
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EPAP
control
Arm Description
Provent Sleep Apnea Therapy.
Outcomes
Primary Outcome Measures
Apnea-hypopnea Index
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01703663
First Posted
October 5, 2012
Last Updated
August 19, 2016
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01703663
Brief Title
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Official Title
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Obstructive Sleep Apnea
Keywords
Stroke, Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPAP
Arm Type
Experimental
Arm Description
Provent Sleep Apnea Therapy.
Arm Title
control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
EPAP
Other Intervention Name(s)
Provent Sleep Apnea Therapy.
Primary Outcome Measure Information:
Title
Apnea-hypopnea Index
Description
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.
Time Frame
night 1 and night 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin L Brown, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27306393
Citation
Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120.
Results Reference
derived
Learn more about this trial
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
We'll reach out to this number within 24 hrs