Completed

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

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What is being tested

EPAP

Device
Who is being recruted

Apnea+13

+ Brain Diseases

+ Cardiovascular Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: October 13, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01703663
Principal SponsorUniversity of Michigan
Last updated: October 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersVascular DiseasesSleep Disorders, IntrinsicDyssomniasIschemic StrokeSleep Apnea SyndromesSleep Apnea, ObstructiveStroke

Criteria

1 inclusion criteria required to participate
adults with an ischemic stroke (including TIA with infarction) within the prior 14 days
12 exclusion criteria prevent from participating
An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
Current use of CPAP, mechanical ventilation, or supplemental oxygen
Current use of any transnasal tube (eg dobhoff tube)
Inability to provide informed consent
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Provent Sleep Apnea Therapy.

Group II

No Intervention

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan

Ann Arbor, United StatesOpen University of Michigan in Google Maps
CompletedOne Study Center