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Device

Respiratory Monitoring Techniques for Neuromuscular Disease

N/A
Recruiting
Led By Thomas Shaffer, PhD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after test
Awards & highlights

Study Summary

This trial will compare a new breathing monitor (pneuRIP) to an existing one, to measure breathing patterns in 20 children (10 normal, 10 with difficulties).

Who is the study for?
This trial is for children who are either healthy or have mild breathing difficulties due to neuromuscular disease. Participants must be able to understand and follow spoken instructions. Children with severe breathing problems cannot take part.Check my eligibility
What is being tested?
The study is testing a new respiratory monitor called pneuRIP, which uses bands around the chest to measure breathing without being invasive. It's being compared with an existing system, Respitrace, in both healthy children and those with mild neuromuscular-related breathing issues.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring systems that simply measure breath without affecting the body directly, there are no expected side effects from using the pneuRIP or Respitrace systems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after test
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after test for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breathing rate
Secondary outcome measures
Labored breathing Index
Percent rib cage
Phase Difference

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: pneuRIP(breathing with resistance)Experimental Treatment2 Interventions
Testing the subjects breathing with resistance
Group II: Respitrace system (Carefusion) (breathing without resistance)Active Control1 Intervention
Testing subjects breathing without resistance

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
124 Previous Clinical Trials
18,131 Total Patients Enrolled
Thomas Shaffer, PhDPrincipal InvestigatorNemours

Media Library

pneuRIP (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02851043 — N/A
Neuromuscular Disease Research Study Groups: pneuRIP(breathing with resistance), Respitrace system (Carefusion) (breathing without resistance)
Neuromuscular Disease Clinical Trial 2023: pneuRIP Highlights & Side Effects. Trial Name: NCT02851043 — N/A
pneuRIP (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02851043 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals within the age range of 55 and above accepted for this clinical research?

"As mandated by the requirements for enrolling in this clinical trial, participants must fall between the ages of 11 and 17."

Answered by AI

Is enrollment open for this medical experiment?

"According to clinicaltrials.gov, this experiment has been actively recruiting since it was initially advertised on August 1st 2014 and the listing's content was most recently updated in March 14th 2023."

Answered by AI

How can I join this clinical experiment?

"To be eligible for this research project, the subject must have a neuromuscular disorder and fall within an age range of 11 to 17 years. Approximately 20 participants are currently being sought after."

Answered by AI

How many people have been enrolled in this research protocol?

"Affirmative. According to information on clinicaltrials.gov, this investigation is actively recruiting patients with 20 participants needed from 1 location. The trial was first published on August 1st 2014 and the latest update occurred at March 14th 2023."

Answered by AI
~1 spots leftby Sep 2024