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OpenTrials
Completed

NCT Number: NCT01703663

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

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.

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Key information

Conditions

Ischemic Stroke Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPAP

Device

Other names: Provent Sleep Apnea Therapy.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2012
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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