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TerminatedNCT02230020EHFTUpdated Aug 8, 2017

Efficacy of High Flow Therapy in COPD At Home

An observational study in COPD, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Johns Hopkins University · Observational

Why this study was terminated
Sponsor funding
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
8
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COPD
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In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic Obstructive Pulmonary Disease

Inclusion criteria

    1. Consenting adults over the age of 18 with COPD

Exclusion criteria

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:

      <!-- -->

      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:

      <!-- -->

      1. Pain control (besides NSAIDs)
      2. Sleep medication
      3. Benzodiazepines
      4. Methadone
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Nasal High Flow

    All subjects are in this group

    Device: Nasal High Flow

Interventions

  • DeviceNasal High Flow
06

What researchers measure

Primary outcomes

  1. Lung Function

    Spirometry will be performed before and after each sleep study

    Time frame: Baseline and 1 month

  2. Dyspnea score

    Borg scale score before and after each sleep study

    Time frame: Baseline and 1 month

  3. Sleep quality

    Sleep architecture assessed from sleep studies

    Time frame: Baseline and 1 month

  4. Quality of life

    St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath

    Time frame: Baseline and 1 month

07

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02230020
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Sep 3, 2014
Start date
Aug 15, 2013
Primary completion
Dec 13, 2015
Completion
Dec 13, 2015
Last update
Aug 8, 2017

Study contacts

Jason Kirkness, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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