Efficacy of High Flow Therapy in COPD At Home

NCT ID: NCT02230020

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-15

Study Completion Date

2015-12-13

Brief Summary

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Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.

Detailed Description

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Conditions

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COPD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Nasal High Flow

All subjects are in this group

Nasal High Flow

Intervention Type DEVICE

Interventions

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Nasal High Flow

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Consenting adults over the age of 18 with COPD

Exclusion Criteria

* 1\. Apnea Hypopnea Index\>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:

1. myocardial infarction in past 3 months
2. revascularization procedure in past 3 months
3. implanted cardiac pacemaker or ICD
4. unstable arrhythmias
5. congestive heart failure with ejection fraction \< 40%
6. uncontrolled hypertension (BP \> 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:

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1. Jaundice
2. ascites
3. history of recurrent gastrointestinal bleeding
4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:

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1. Pain control (besides NSAIDs)
2. Sleep medication
3. Benzodiazepines
4. Methadone
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Kirkness, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00084508

Identifier Type: -

Identifier Source: org_study_id

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