An interventional study of On Demand Humidification system Mark 2 in Neuromuscular Diseases, sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-10.
Sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization (part of Philips) · Not applicable, Interventional, and Supportive care
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Among 21 studies in Neuromuscular Diseases with a site in Netherlands — 7 open to participants now, 11 under way, 3 of them phase 3. Neuromuscular Diseases · Netherlands.
Among the 21 studies in Neuromuscular Diseases with a site in Netherlands, this one is the 16th largest by enrollment of the 19 interventional ones that give a count, is the only one that started in 2018, is one of 8 with no phase, and was the 4th registered.
361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.
Browse Neuromuscular Diseases studies →7 of the 21 studies in Neuromuscular Diseases with a site in Netherlands are open now. Recruiting first, the newest first:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Ages 18+
Avidity Biosciences, Inc. · Sites in Netherlands, Australia, Belgium and 7 more countries
Ages 7–16 · Men only
AstraZeneca · Sites in Netherlands, United States, Canada and 7 more countries
Ages 18–70
Hasselt University · Sites in Netherlands
Ages 16+
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Ages 18+
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 6
First in 2012; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 30 across 204 interventional studies indexed under Neuromuscular Diseases.
Median enrollment 70 across the 19 interventional studies, 1,025 across the 2 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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12 of 21 have an industry lead sponsor. The 10 most frequent:
This study is registered under Philips Electronics Nederland B.V. acting through Philips CTO organization, one of the names counted as Philips. Under that name alone:
Philips Electronics Nederland B.V. acting through Philips CTO organization is the lead sponsor of 17 studies on the registry; none are open to participants now.
Philips has 1 study filed under Neuromuscular Diseases — fewer than ten, so there is no comparison to draw.
3 of the studies in Neuromuscular Diseases with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT06573866Radboud University Medical CenterEnhancement of Quality of Work And Life | 2027-03-04 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
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Among the 21 studies in Neuromuscular Diseases with a site in Netherlands, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a neuromuscular disorder who:
Exclusion Criteria:
Clinically unstable, i.e.,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
on demand humidification
Device: On Demand Humidification system Mark 2
The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.
optimum comfortable amount of on-demand humidification
questionnaire based on Borg Scale and Visual Analog scale
Time frame: 3 hours
optimum comfortable amount of on-demand humidification
heart rate
Time frame: 3 hours
optimum comfortable amount of on-demand humidification
breathing rate
Time frame: 3 hours
optimum comfortable amount of on-demand humidification
SpO2
Time frame: 3 hours
optimum comfortable amount of on-demand humidification
transcutaneous CO2
Time frame: 3 hours
optimum comfortable amount of on-demand humidification
number of mucus clearance events
Time frame: 3 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jul 2018, 6 months.
Of 84 interventional studies with no phase under Neuromuscular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Philips Electronics Nederland B.V. acting through Philips CTO organization →