NCT05873504

Brief Summary

This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2023Dec 2026

First Submitted

Initial submission to the registry

April 16, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3.6 years

First QC Date

April 16, 2023

Last Update Submit

February 17, 2026

Conditions

Airway Clearance Impairment

Outcome Measures

Primary Outcomes (1)

  • Respiratory assess and treat (RAAT) score

    The RAAT score range from 0-50.

    Change from baseline RAAT score at 12 hours

Study Arms (2)

High Oscillatory Index Device

EXPERIMENTAL

Patients in this arm will receive a device that vibrates with high oscillatory index.

Device: High Oscillatory Index Device

Low Oscillatory Index Device

ACTIVE COMPARATOR

Patients in this arm will receive a device that vibrates with low oscillatory index.

Device: Low Oscillatory Index Device

Interventions

High Oscillatory Index DeviceDEVICE

This device is commonly used to provide assistance with airway secretion clearance.

Also known as: Aerobika
High Oscillatory Index Device
Low Oscillatory Index DeviceDEVICE

This device is commonly used to provide assistance with airway secretion clearance.

Also known as: VibraPEP
Low Oscillatory Index Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years or older
  • Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5

You may not qualify if:

  • Younger than 18 years of age
  • Pregnant
  • Slow vital capacity (SVC) of \<10 mL/kg
  • Unable to follow instructions
  • Currently receiving cough assist, vest therapy or intrapulmonary percussive ventilation
  • Received more than 1 therapy session using oscillatory index device
  • Multiple ICU admission with previous study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Central Study Contacts

Lauren Harnois, MSc

CONTACT

312-947-8898Lauren_J_Harnois@rush.edu

Ramandeep Kaur, PhD

CONTACT

Ramandeep_Kaur@rush.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2023

First Posted

May 24, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)