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Home-Initiated NiPPV for Sleep Apnea

N/A
Recruiting
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 5-17 years old
Newly prescribed NiPPV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will evaluate if starting a breathing machine (NiPPV) at home is feasible and safe for children with medical complexity, potentially improving their quality of life and survival.

Who is the study for?
This trial is for children aged 5-17 with complex medical needs who have trouble breathing at night and are starting to use a NiPPV breathing machine. They must be able to tolerate an awake NiPPV trial, provide informed consent, and not be at high risk of complications or involved in other studies that could affect the outcome.Check my eligibility
What is being tested?
The study tests initiating noninvasive positive pressure ventilation (NiPPV) at home versus in a sleep lab for children with medical complexity. It aims to determine if starting treatment at home is feasible and safe by randomly assigning participants to either setting.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort from wearing the mask, skin irritation where the mask fits, dry nose or throat, bloating, eye irritation, leaks around the mask edges causing less effective treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 5 and 17 years old.
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I have been newly prescribed non-invasive positive pressure ventilation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eligible patients randomized
Proportion of patients that crossover based on safety criteria
Recruitment and retention rate
Secondary outcome measures
Caregiver reported Sense of Mastery
Difference in expiratory positive airway pressure based on home NiPPV titration and PSG titration in the intervention arm
Difference in inspiratory positive airway pressure based on home NiPPV titration and PSG titration in the intervention arm
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Home Initiation of NiPPVExperimental Treatment1 Intervention
NiPPV settings will be titrated during an awake NiPPV trial by the respiratory therapist. Once NiPPV equipment is obtained and NiPPV is used at home (time 0), further titration of the NiPPV settings will occur on an outpatient basis guided by remote telemonitoring and home overnight oximetries at 1, 4, and 12 weeks. Additional titration of NiPPV settings may be guided by reported participant symptoms and comfort, as per standard of care. Participants will complete an in-hospital PSG after 12 weeks, during which NiPPV settings are titrated during the night by a PSG technologist to determine optimal settings according to current international guidelines.
Group II: Standard of careActive Control1 Intervention
Standard of care is NiPPV initiation during a one-night, in-hospital PSG, during which NiPPV settings are titrated during the night by a PSG technologist to determine optimal settings according to current international guidelines. Once NiPPV equipment is obtained and NiPPV is used at home (time 0), NiPPV setting changes may occur at 1, 4, and 12 weeks when participants are contacted by the respiratory therapist. Additional titration of NiPPV settings may be guided by reported participant symptoms and comfort, as per standard of care.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,454 Total Patients Enrolled

Media Library

Home Initiation of NiPPV Clinical Trial Eligibility Overview. Trial Name: NCT05881031 — N/A
Sleep Apnea Research Study Groups: Standard of care, Home Initiation of NiPPV
Sleep Apnea Clinical Trial 2023: Home Initiation of NiPPV Highlights & Side Effects. Trial Name: NCT05881031 — N/A
Home Initiation of NiPPV 2023 Treatment Timeline for Medical Study. Trial Name: NCT05881031 — N/A

Frequently Asked Questions

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

Is this medical trial open to individuals who exceed the age of 20?

"For enrollment in this clinical trail, the youngest participants must be 5 years of age and the oldest can not exceed 17.5 years old."

Answered by AI

Are there any limitations on who can register for this clinical research?

"To gain admittance to this research project, participants must have sleep apnea and be between 5-17.5 years of age. A maximum of 24 patients will be accepted into the trial."

Answered by AI

What is the total enrollment rate for this research project?

"Affirmative. According to the material hosted on clinicaltrials.gov, this trial was first announced on May 25th 2023 and is presently enrolling 24 participants from a singular medical facility."

Answered by AI

Are there still vacancies available for enrolment in this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this trial is still actively seeking participants, having been posted on May 25th 2023 and edited for accuracy as recently as May 26th 2023. The medical study needs 24 patients from a single site in order to be completed successfully."

Answered by AI

What are the key aims of this medical research endeavor?

"This trial will assess the primary outcome of Proportion of eligible patients randomized over a period of two years. Secondary outcomes include the Proxy-reported Psychological Scale (percentage rank) from KIDSCREEN-52, with lower scores indicating decreased life satisfaction; T-value proxy assessments which have an average score of 50 and deviation 10 with elevated values correlating to improved quality of life; and Self Reported Psychological Scale (percentage rank), again using KIDSCREEN-52 where lower numbers indicate reduced contentment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Reshma Amin 2023. "Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05881031.
~13 spots leftby May 2025
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