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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01703663
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
Devin Brown, 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Obstructive Sleep Apnea Device: EPAP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Study Start Date : November 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: EPAP
Provent Sleep Apnea Therapy.
Device: EPAP
Other Name: Provent Sleep Apnea Therapy.

No Intervention: control

Primary Outcome Measures :
  1. Apnea-hypopnea Index [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Devin Brown, Professor, University of Michigan Identifier: NCT01703663     History of Changes
Other Study ID Numbers: U037625
First Posted: October 10, 2012    Key Record Dates
Results First Posted: October 13, 2016
Last Update Posted: October 13, 2016
Last Verified: August 2016

Keywords provided by Devin Brown, 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