Efficacy of High Flow Therapy in COPD At Home

Terminated

• Conditions: COPD
• Interventions: Device: Nasal High Flow

• Registration Number: NCT02230020
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-08-15
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Primary Completion: 2015-12-13
• Study Completion: 2015-12-13
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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:

  2. myocardial infarction in past 3 months

  3. revascularization procedure in past 3 months

  4. implanted cardiac pacemaker or ICD

  5. unstable arrhythmias

  6. congestive heart failure with ejection fraction < 40%

  7. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nasal High Flow	Nasal High Flow	All subjects are in this group

Primary Outcome Measures

Name	Time	Method
Lung Function	Baseline and 1 month	Spirometry will be performed before and after each sleep study
Quality of life	Baseline and 1 month	St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath
Dyspnea score	Baseline and 1 month	Borg scale score before and after each sleep study
Sleep quality	Baseline and 1 month	Sleep architecture assessed from sleep studies

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States