Muscular DystrophiesNCT04313595
Device for Breathing Frequency Monitoring in Muscular Dystrophy
A study testing RespirHó in people with Muscular Dystrophies, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- RespirHó
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2018to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- documented DMD or LGMD2
- loss of independent ambulation (wheelchair-bound patients)
- ability to understand and follow test instructions and to report pain and discomfort.
Who cannot join
- presence of metal implants and cardiac pacemakers
- relevant concomitant comorbidities (e.g.epilepsy)
- behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy
Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function
- Conditions
- Muscular Dystrophies
- Being tested
- RespirHó
- Medical subject headings
- Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespirHóDevice
The system is a wearable, unobtrusive inertial-sensor-based device for long-term breathing pattern monitoring, also during daily life activities. It consists of three IMU-sensor units (3-axis accelerometer, 3-axis gyroscope, 3-axis magnetometer), positioned respectively on the patient's abdomen and thorax, and on a body area integral with thorax but not affected by espiratory movements. The peripheral units, placed on thorax and abdomen are used to record orientation changes during respiratory movements. The third unit is a central reference unit (hereafter CRU) that receives data from the other two units, save them on an SD card and communicate via Bluetooth with a smartphone / tablet / PC. Moreover, this unit detects only non-respiratory movement, representing not only a pure source of "noise" that must be removed from the thoracic and bdominal signals, but also a pure source of additional information regarding the state of ctivity of the subject .
| Study group | Role | What they receive |
|---|---|---|
| Breathing frequency monitoring | Experimental | Not described Receives: Device: RespirHó |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the device
Recording of any adverse events
Measured: After 24 hours of continued use
Usability of the device (System Usability Scale)
System Usability Scale (SUS acceptance and wearability of the device):the scores range from 0 to 100 in 2.5-point increments, with higher values meaning high perceived usability of the system
Measured: After 24 hours of continued use
Acceptability of the device (Technological Acceptance Measure)
Technological Acceptance Measure (TAM) questionnaire appropriate for the medical device: with higher values meaning high acceptance of the system
Measured: After 24 hours of continued use
Secondary outcomes (1)
Accuracy in measuring the breathing frequency
Comparison between the measures of respiratory rate by using the device and by using already validated instrumentation: Optoelectronic Plethysmography (OEP), optoelectronic movement analysis system.
Chest wall movements during breathing are simultaneously recorded by the RespirHó device and by Optoelectronic Plethysmography (OEP), in static conditions, and in particular, in supine and seated positions.
OEP allows assessment of ventilatory and breathing pattern by measuring chest-wall movements related to breathing, by using motion capture principles.
Using OEP as reference method it is possible to compare the data recorded with the thoracic and abdominal units of the device RespirHó with those obtained by using OEP for the thoracic and abdominal compartments
Measured: Immediately after application of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start29 Jul 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313595
- Sponsor's protocol ID
- 534
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT04313595
- Acronym / sponsor ID
- 534
- Conditions
- Muscular Dystrophies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 29 Jul 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 18 Mar 2020 (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.
Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing frequency monitoring | Experimental | Device: RespirHó |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- documented DMD or LGMD2
- loss of independent ambulation (wheelchair-bound patients)
- ability to understand and follow test instructions and to report pain and discomfort.
Key exclusion criteria (3 listed)
- presence of metal implants and cardiac pacemakers
- relevant concomitant comorbidities (e.g.epilepsy)
- behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).
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 |
|---|---|---|
| RespirHóThe system is a wearable, unobtrusive inertial-sensor-based device for long-term breathing pattern monitoring, also during daily life activities. It consists of three IMU-sensor units (3-axis accelerometer, 3-axis gyroscope, 3-axis magnetometer), positioned respectively on the patient's abdomen and thorax, and on a body area integral with thorax but not affected by espiratory movements. The peripheral units, placed on thorax and abdomen are used to record orientation changes during respiratory movements. The third unit is a central reference unit (hereafter CRU) that receives data from the other two units, save them on an SD card and communicate via Bluetooth with a smartphone / tablet / PC. Moreover, this unit detects only non-respiratory movement, representing not only a pure source of "noise" that must be removed from the thoracic and bdominal signals, but also a pure source of additional information regarding the state of ctivity of the subject . | Device | Breathing frequency monitoring |
Primary outcome
Safety of the device
Time frame: After 24 hours of continued use
Recording of any adverse events
Usability of the device (System Usability Scale)
Time frame: After 24 hours of continued use
System Usability Scale (SUS acceptance and wearability of the device):the scores range from 0 to 100 in 2.5-point increments, with higher values meaning high perceived usability of the system
Acceptability of the device (Technological Acceptance Measure)
Time frame: After 24 hours of continued use
Technological Acceptance Measure (TAM) questionnaire appropriate for the medical device: with higher values meaning high acceptance of the system
1 secondary outcome
Accuracy in measuring the breathing frequency
Time frame: Immediately after application of the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RespirHó in people with Muscular Dystrophies, run by IRCCS Eugenio Medea at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2020. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the device (time frame: After 24 hours of continued use). The study lists 3 primary outcomes in all. 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 18 Mar 2020.