Efficacy of High Flow Therapy in COPD At Home

NCT02230020 | Terminated

• 1 other identifier: NA_00084508
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (4)

• Lung Function

  Spirometry will be performed before and after each sleep study

  Baseline and 1 month

• Dyspnea score

  Borg scale score before and after each sleep study

  Baseline and 1 month

• Sleep quality

  Sleep architecture assessed from sleep studies

  Baseline and 1 month

• Quality of life

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

  Baseline and 1 month

Study Arms (1)

Nasal High Flow

All subjects are in this group

Device: Nasal High Flow

Interventions

Nasal High Flow DEVICE

Nasal High Flow

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease

You may qualify if:

• \. Consenting adults over the age of 18 with COPD

You may not qualify if:

• \. 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:
• myocardial infarction in past 3 months
• revascularization procedure in past 3 months
• implanted cardiac pacemaker or ICD
• unstable arrhythmias
• congestive heart failure with ejection fraction \< 40%
• 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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• Jaundice
• ascites
• history of recurrent gastrointestinal bleeding
• 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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• Pain control (besides NSAIDs)
• Sleep medication

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Biospecimen

Retention: NONE RETAINED

CRP Fibrinogen

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Kirkness, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: August 15, 2013
• Primary Completion: December 13, 2015
• Study Completion: December 13, 2015
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (1)