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Custom mask for Non-Invasive Ventilation

N/A

Recruiting

Led By Joanna E MacLean, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established on non-invasive ventilation as part of their treatment plan.

Children between 8-12 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of trial - 1 month

Awards & highlights

Study Summary

This trial aims to address the challenge of finding suitable masks for children who need non-invasive ventilation (NIV). The current options are limited and do not always fit well on children's faces, which

Who is the study for?

This trial is for children aged 8-12 who are patients at the Stollery Children's Hospital and have been using non-invasive ventilation (NIV) as part of their treatment. They should be established on NIV but not adhering optimally to the therapy.Check my eligibility

What is being tested?

The study compares custom-made masks, designed from a facial scan for a better fit, with current commercial masks used in NIV for children. It will assess mask leak, comfort, treatment efficacy through sleep studies, compliance data from machines, and user preference.See study design

What are the potential side effects?

Potential side effects may include discomfort due to poor mask fit or skin irritation where the mask touches the face. However, since this trial aims to improve fit with custom masks, such issues might be reduced.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I use a breathing machine as part of my treatment.

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I am between 8 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of trial - 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of trial - 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of trial - 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in apnea hypopnea index

Change in average time used/night

Change in obstructive apnea hypopnea index

+3 more

Secondary outcome measures

Change in mask air leak (bench testing)

Change in mask comfort - parent (visual likert scale1-9)

Change in mask comfort - participant (visual likert scale, 1-9)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Custom maskExperimental Treatment1 Intervention

Custom mask based on 3D facial photograph for administration of non-invasive ventilation

Group II: Current commercial maskActive Control1 Intervention

Current commercial mask used by the participant for administration of non-invasive ventilation

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,162 Total Patients Enrolled

Stollery Children's HospitalOTHER

23 Previous Clinical Trials

25,727 Total Patients Enrolled

Joanna E MacLean, MD, PhDPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

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

Are there any available openings for patients to participate in this study?

"Indeed, the data on clinicaltrials.gov confirms that this trial is currently seeking participants. The trial was initially posted on December 15, 2023 and last updated on January 3, 2024. This study aims to enroll a total of 15 patients at one specific location."

Answered by AI

Can individuals enroll themselves in this medical research study?

"The trial aims to enroll 15 participants aged between 8 and 12 who are currently using non-invasive ventilation as part of their treatment plan. It is crucial that these children have been clinically supervised by the Non-invasive Ventilation Clinic at Stollery Children's Hospital."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary objective of this trial is to evaluate the change in obstructive apnea hypopnea index, with measurements taken at baseline using a commercial mask study and repeated measures after 1 month using a custom mask. Secondary outcomes include assessing changes in mask comfort as reported by participants on a visual Likert scale ranging from 1 to 9, measuring unintended mask leaks through bench testing, and evaluating mask comfort as reported by parents on a visual Likert scale ranging from 1 to 9."

Answered by AI

What is the overall patient enrollment count for this particular research investigation?

"Yes, according to the information available on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted on December 15th, 2023 and most recently updated on January 3rd, 2024. The research team aims to enroll a total of 15 patients at one single location."

Answered by AI

Could individuals younger than 85 years old be considered as potential participants for this research investigation?

"To be eligible for this clinical trial, patients must fall within the age range of 8 to 12. Among the trials available, there are a total of 45 studies specifically targeting individuals under the age of 18 and an additional 20 studies focused on patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Custom Non-invasive Ventilation Masks in Children

2023. "Custom Non-invasive Ventilation Masks in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336136.