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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT01703663
First received: October 5, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 Phase
Ischemic Stroke
Obstructive Sleep Apnea
Device: EPAP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

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 ]

Estimated Enrollment: 18
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01703663

Contacts
Contact: Devin Brown, MD 7349269075 devinb@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Devin Brown, MD    734-936-9075    devinb@umich.edu   
Principal Investigator: Devin Brown, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Devin Brown, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01703663     History of Changes
Other Study ID Numbers: U037625
Study First Received: October 5, 2012
Last Updated: November 28, 2012
Health Authority: United States: University of Michigan IRBMED.

Keywords provided by University of Michigan:
Stroke
Sleep Apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Stroke
Cerebral Infarction
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014