Oscillation and Lung Expansion (OLE) therapy for Oppenheim Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Science 37, Durham, NC
Oppenheim Disease
Oscillation and Lung Expansion (OLE) therapy - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

The study will be a non-randomized open label pilot study using an observational design comparing a retrospective control period to an active treatment period with oscillation and lung expansion (OLE) therapy.

Treatment Effectiveness

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 6 months

6 months
Adherence to treatment regimen
Frequency of exacerbations of pulmonary disease requiring medical intervention
Impact of OLE therapy on patient quality of life using the Severe Respiratory Insufficiency (SRI) questionnaire
Number of ICU admissions
Number of antibiotic use days during episodes of pneumonia
Number of hospitalizations
Number of inpatient hospital days
Number of outpatient visits for pulmonary complications
6 months.
Satisfaction with OLE therapy
Monthly for 6 months
Maximal Inspiratory Pressure
Oxygen (O2) saturation
Peak Cough Flow
Slow Vital Capacity

Trial Safety

Trial Design

1 Treatment Group

Intervention
1 of 1
Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: Oscillation and Lung Expansion (OLE) therapy · No Placebo Group · N/A

Intervention
Device
Experimental Group · 1 Intervention: Oscillation and Lung Expansion (OLE) therapy · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Science 37 · Durham, NC
Photo of durham 1Photo of durham 2Photo of durham 3
2018First Recorded Clinical Trial
0 TrialsResearching Oppenheim Disease
2 CompletedClinical Trials

Who is running the clinical trial?

Hill-RomLead Sponsor
33 Previous Clinical Trials
2,799 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a documented diagnosis of NMD.
You have had one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.