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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Ischemic Stroke
Obstructive Sleep Apnea

Treatments

Device: EPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT01703663
U037625

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

EPAP
Experimental group
Description:
Provent Sleep Apnea Therapy.
Treatment:
Device: EPAP
control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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