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OLE Therapy for Neuromuscular Disease

N/A

Recruiting

Research Sponsored by Hill-Rom

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, requiring unplanned or unscheduled medical intervention

Documented diagnosis of neuromuscular disease (NMD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will compare the effects of a new therapy, oscillation and lung expansion (OLE), to a control period.

Who is the study for?

This trial is for people aged 5-80 with neuromuscular disease who've had at least one serious lung issue in the last 6 months or two in the past year. They must be able to do OLE therapy and give consent. It's not for those with fast-progressing diseases, recent severe lung problems, upcoming hospital stays, pregnancy, or prior OLE use.Check my eligibility

What is being tested?

The study tests Oscillation and Lung Expansion (OLE) therapy on patients with neuromuscular disease by observing them before and after treatment without comparing to a separate group. The goal is to see if OLE helps reduce lung complications.See study design

What are the potential side effects?

Since this is an observational study of a physical therapy technique rather than a drug trial, specific side effects are not listed but may include discomfort during the procedure or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had serious breathing issues needing unexpected medical help recently.

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I have been diagnosed with a neuromuscular disease.

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I am between 5 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of exacerbations of pulmonary disease requiring medical intervention

Secondary outcome measures

Adherence to treatment regimen

Impact of OLE therapy on patient quality of life using the Severe Respiratory Insufficiency (SRI) questionnaire

Maximal Inspiratory Pressure

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hill-RomLead Sponsor

33 Previous Clinical Trials

2,799 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the selection criteria for this clinical trial include seniors?

"This trial is open to individuals aged 5 or above, but must be younger than 80 years old."

Answered by AI

Who meets the criteria to be eligible for the trial?

"This medical trial seeks 70 participants aged between 5 and 80 with a clinically diagnosed neuromuscular disorder known as Oppenheim Disease. Furthermore, these subjects must have experienced at least one respiratory episode necessitating unplanned treatment within the past half-year or two episodes in the last year. Additionally, they should be capable of following OLE therapy instructions and providing signed informed consent (or assent if applicable)."

Answered by AI

What is the uppermost participant threshold for this trial?

"Affirmative, the details on clinicaltrials.gov demonstrate that this research trial is actively enrolling participants. It was initially posted in November 2021 and its most recent update came in May 2022; it requires 70 volunteers from a single site to participate."

Answered by AI

Are there any openings for this research project at present?

"Affirmative. The clinical trial registry hosted on clinicaltrials.gov states that the medical experiment, which was initially published on November 4th 2021 is currently seeking participants. This research endeavour requires 70 individuals to be recruited from 1 separate clinic sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oscillation and Lung Expansion (OLE) for Treatment of Neuromuscular Disease Patients

2021. "Oscillation and Lung Expansion (OLE) for Treatment of Neuromuscular Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05366010.