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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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