← Back to Search

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
Must not have
Cardiac disease at risk of hemodynamic instability with NiPPV initiation (eg cardiac dysfunction (ejection fraction <45%), pulmonary hypertension (mean pulmonary artery pressure ≥ 20 mmHg on right heart catheterization or suggestive echocardiogram findings in the opinion of a pediatric cardiologist), or single ventricle)
Exclusion of study participants if the caregiver or participant is not English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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
Select...
I am between 5 and 17 years old.
Select...
I have been newly prescribed non-invasive positive pressure ventilation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart issues that could worsen with certain breathing treatments.
Select...
I or my caregiver can communicate in English.
Select...
I have severe sleep issues with high CO2 levels or many breathing pauses per hour.

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
692 Previous Clinical Trials
6,946,719 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
~10 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top