CompletedNot Applicable

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

United States10 participantsStarted 2017-03-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented diagnosis of CF or MND * Age ≥ 18 years * Signed informed consent Exclusion Criteria: * 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

What they're measuring

Patient / Caregiver Satisfaction Scores

Timeframe: 90 days

Patient / Caregiver Satisfaction Scores

Timeframe: 90 days

Trial details

NCT IDNCT03797677

SponsorHill-Rom

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-30

Results submitted2024-04-04

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