MN4000 for Treatment of CF and MND Patients in the Home Setting

Completed · Not applicable

Conditions studied: Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment

In brief

The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000. This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.

Key facts

Study ID

NCT03797677

Run by

Hill-Rom

People needed

10

Starts

2017-03-09

Expected to finish

2017-11-30

Last updated by the study team

2024-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of CF or MND
• Age ≥ 18 years
• Signed informed consent

You may not qualify if…

• Requirement for continuous mechanical ventilation
• Anticipated requirement for hospitalization within the next three months
• History of pneumothorax within past 6 months
• History of hemoptysis requiring embolization within past 12 months
• Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
• Inability to perform MN4000 therapy as directed
• Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol

Where it is running

• Northwestern — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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