Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Devin Brown, University of Michigan Identifier:
First received: October 5, 2012
Last updated: August 19, 2016
Last verified: August 2016

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.

Condition Intervention
Ischemic Stroke
Obstructive Sleep Apnea
Device: EPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Apnea-hypopnea Index [ Time Frame: night 1 and night 2 ] [ Designated as safety issue: No ]
    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.

Enrollment: 40
Study Start Date: November 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPAP
Provent Sleep Apnea Therapy.
Device: EPAP
Other Name: Provent Sleep Apnea Therapy.
No Intervention: control


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01703663

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Devin L Brown, MD University of Michigan
  More Information

Responsible Party: Devin Brown, Professor, University of Michigan Identifier: NCT01703663     History of Changes
Other Study ID Numbers: U037625 
Study First Received: October 5, 2012
Results First Received: May 19, 2016
Last Updated: August 19, 2016
Health Authority: United States: University of Michigan IRBMED.

Keywords provided by University of Michigan:
Sleep Apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on October 21, 2016