Neuromuscular DiseasesNCT02851043
Non-Invasive Respiratory Monitor
A study testing pneuRIP (breathing with resistance) and Respitrace system (Carefusion) (breathing without resistance) in people with Neuromuscular Diseases and Healthy Volunteers, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases, Healthy Volunteers
- What is being tested?
- pneuRIP (breathing with resistance) and Respitrace system (Carefusion) (breathing without resistance)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2027
- Phase
- Interventional
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteers
- Neuromuscular disease subjects with mild breathing difficulty
- Capable of following verbal instructions
Who cannot join
- Severe breathing difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, 19899
Tariq Rahman, PhD, 302-651-6831, trahman@nemours.org
About this study
This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.
Read the detailed description
Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.
Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.
- Conditions
- Neuromuscular Diseases, Healthy Volunteers
- Being tested
- pneuRIP (breathing with resistance), Respitrace system (Carefusion) (breathing without resistance)
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneuRIP (breathing with resistance)Device
subjects are given a resistance element to breath through
Respitrace system (Carefusion) (breathing without resistance)Device
subjects are asked to breath normally
| Study group | Role | What they receive |
|---|---|---|
| pneuRIP(breathing with resistance) | Experimental | Testing the subjects breathing with resistance Receives: Device: pneuRIP (breathing with resistance); Device: Respitrace system (Carefusion) (breathing without resistance) |
| Respitrace system (Carefusion) (breathing without resistance) | No intervention | Testing subjects breathing without resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing rate
The breathing rate is measured by two different monitors
Measured: Immediately after test
Secondary outcomes (3)
Labored breathing Index
The labored breathing index is measured by two different monitors
Measured: Immediately after test
Phase Difference
The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Measured: Immediately after test
Percent rib cage
The percentage of breathing performed by the rib cage is measured by two different monitors
Measured: Immediately after test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tariq Rahman, Nemours Children's Clinic
- Investigators
- Thomas Shaffer, PhD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851043
- Sponsor's protocol ID
- 613308
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2016
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Respiratory Monitor
- ClinicalTrials.gov ID
- NCT02851043
- Acronym / sponsor ID
- 613308
- Conditions
- Neuromuscular Diseases, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- 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.
This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.
Detailed description
Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.
Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneuRIP(breathing with resistance) | Experimental | Device: pneuRIP (breathing with resistance), Device: Respitrace system (Carefusion) (breathing without resistance)Testing the subjects breathing with resistance |
| Respitrace system (Carefusion) (breathing without resistance) | No intervention | –Testing subjects breathing without resistance |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy volunteers
- Neuromuscular disease subjects with mild breathing difficulty
- Capable of following verbal instructions
Key exclusion criteria (1 listed)
- Severe breathing difficulties
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 |
|---|---|---|
| pneuRIP (breathing with resistance)subjects are given a resistance element to breath through | Device | pneuRIP(breathing with resistance) |
| Respitrace system (Carefusion) (breathing without resistance)subjects are asked to breath normally | Device | pneuRIP(breathing with resistance) |
Primary outcome
Breathing rate
Time frame: Immediately after test
The breathing rate is measured by two different monitors
3 secondary outcomes
Labored breathing Index
Time frame: Immediately after test
Phase Difference
Time frame: Immediately after test
Percent rib cage
Time frame: Immediately after test
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 13 Oct 2026.
- 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.
Thomas Shaffer, PhD principal investigator
Nemours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneuRIP (breathing with resistance) and Respitrace system (Carefusion) (breathing without resistance) in people with Neuromuscular Diseases and Healthy Volunteers, run by Nemours Children's Clinic at 1 site in United States.
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 1 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 13 Oct 2026. 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 United States. 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 Tariq Rahman, PhD (302 651 6831, trahman@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing rate (time frame: Immediately after test). 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 13 Oct 2026.