Neuromuscular DiseasesHPforNIVNCT05785637
Polygraphy at Home for Neuromuscular Patients Under Non-invasive Mechanical Ventilation
An observational study of Neuromuscular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Polygraphy diagnostic at home
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic respiratory failure due to neuromuscular diseases under non-invasive mechanical ventilation
Who may be able to join
- Patient ≥ 18 years;
- Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
- Affiliation to the social security scheme;
- Patient has signed the informed consent form to participate to the study.
Who cannot join
- Patient refusal;
- Patient under guardianship;
- Patient under AME scheme;
- Patients living more than 40 km from reference center;
- Patient depending on mechanical ventilation (more than 6 hours daily);
- Rapidly or reversible evolutive neuro-myopathy (Amyotrophic lateral sclerosis, Guillain Barré syndrome, myasthenia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
Garches, 92380
About this study
Official title: Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation
The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).
- Conditions
- Neuromuscular Diseases
- Being tested
- Polygraphy diagnostic at home
- Keywords
- Neuromuscular Diseases, Polygraphy
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygraphy diagnostic at homeProcedure or surgery
Polygraphy diagnostic at home for patients under non-invasive mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Initiation a non-invasive ventilation at night | Neuromuscular patients with chronic respiratory failure who initiate a non-invasive ventilation at night. Receives: Procedure: Polygraphy diagnostic at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gradation of quality of recorded signals at home
Expressed in number of readable signals for which the readability will be expressed in % of record time.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start8 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Responsible party
- Sponsor
- Investigators
- Frédéric Lofaso, MD, PhD, Principal investigator, Department of physiology and functional explorations - Raymond Poincaré Hospital - APHPHélène Prigent, MD, PhD, Study director, Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785637
- Sponsor's protocol ID
- APHP230176
- Other IDs
- 2022-A01925-38
- Acronym
- HPforNIV
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05785637
- Acronym / sponsor ID
- HPforNIV / APHP230176
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular Diseases, Polygraphy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initiation a non-invasive ventilation at night | – | Procedure: Polygraphy diagnostic at homeNeuromuscular patients with chronic respiratory failure who initiate a non-invasive ventilation at night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic respiratory failure due to neuromuscular diseases under non-invasive mechanical ventilation
Key inclusion criteria (4 listed)
- Patient ≥ 18 years;
- Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
- Affiliation to the social security scheme;
- Patient has signed the informed consent form to participate to the study.
Key exclusion criteria (6 listed)
- Patient refusal;
- Patient under guardianship;
- Patient under AME scheme;
- Patients living more than 40 km from reference center;
- Patient depending on mechanical ventilation (more than 6 hours daily);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygraphy diagnostic at homePolygraphy diagnostic at home for patients under non-invasive mechanical ventilation. | Procedure or surgery | Initiation a non-invasive ventilation at night |
Primary outcome
Gradation of quality of recorded signals at home
Time frame: at day 1
Expressed in number of readable signals for which the readability will be expressed in % of record time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Lofaso, MD, PhD principal investigator
Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
Hélène Prigent, MD, PhD study director
Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Lofaso, MD, PhD (+33 (0)1 47 10 79 41, f.lofaso@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gradation of quality of recorded signals at home (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.