Completed

Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

HFCWC with higher pressure/variable-frequency settings

+ HFCWC with lower pressure/mid-frequency settings

Device
Who is being recruted

Cystic Fibrosis+5

+ Digestive System Diseases

+ Infant, Newborn, Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2008
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2008

Actual date on which the first participant was enrolled.

Patients with cystic fibrosis (CF) perform daily airway clearance therapy to facilitate removal of secretions from their airways. Many different techniques are available to achieve this and there is currently no consensus as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO) is used by CF patients throughout the United States and abroad. To perform this therapy, the patient wears a vest which fits over the entire torso and is connected to an air compressor. The compressor generates oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The most commonly used device is The Vest™ Airway Clearance System, (Hill-Rom Inc, St Paul, MN). Adjustment of the inflation pressure and frequency of oscillations affects the volume of displaced air and flow of air measured at the mouth of the patient. Previous studies indicate this form of therapy is as effective as more traditional and cumbersome forms of therapy. However, it is unclear which inflation pressures and oscillator frequencies provide optimal airway clearance. Some studies of sine waveform HFCWO reported the largest volume of air displacement and highest air flow measured at the mouth when using a combination of high inflation pressures with either low (7 - 10 Hz) or high frequencies (18 - 20 Hz), but most CF centers in the United States use HFCWO with lower pressures combined with mid-range frequencies (10 - 14 Hz). Furthermore, there are no previous studies assessing the affect of sine waveform HFCWO settings on sputum production. As a result, there is no consensus on which pressure and frequency settings are most efficacious for CF patients.

Official TitleComparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis
NCT00685035
Principal SponsorUniversity of Minnesota
Last updated: January 27, 2026
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

17 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

Cystic FibrosisDigestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesRespiratory Tract DiseasesGenetic Diseases, Inborn

Criteria

6 inclusion criteria required to participate
History of chronic daily sputum production.

Diagnosis of CF established by sweat chloride > 60 mmol/L.

Age older than 18 years.

Currently on a home therapeutic regimen that includes some form of airway clearance performed with a HFCWO device at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.

Show More Criteria

6 exclusion criteria prevent from participating
Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.

Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.

Chest pain requiring use of narcotic for pain control.

Current participation in another clinical trial.

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

Active Comparator
Half patients randomly assigned to perform HFCWC therapy first with a higher pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period

Group II

Active Comparator
lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency

Study Objectives

Primary Objectives

Secondary 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

Suspended

University of Minnesota Medical Center

Minneapolis, United StatesOpen University of Minnesota Medical Center in Google Maps
CompletedOne Study Center