Actively Recruiting
Single Site Feasibility and Safety Study of Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Led by The Hospital for Sick Children · Updated on 2026-05-07
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Children with medical complexity (CMC) often experience breathing difficulties at night and require a breathing machine called noninvasive positive pressure ventilation (NiPPV). This study evaluates a new way to start NiPPV at home, compared to the usual hospital sleep laboratory initiation, focusing on feasibility and safety. The goal is to improve how NiPPV is started for CMC aged 5 to 17 years old and to support better long-term use and quality of life. Participants will be randomly assigned to start NiPPV either at home using remote telemonitoring or in the hospital sleep lab during an overnight study. The standard hospital method involves a one-night polysomnography (PSG) to set machine settings. The home method uses an awake NiPPV trial, telemonitoring, and home overnight oxygen tests to adjust settings over 12 weeks. Both groups receive follow-up adjustments at 1, 4, and 12 weeks, with the home group also having a PSG after 12 weeks. During the study, families will be contacted regularly to monitor NiPPV use, symptoms, and comfort. Data collected include NiPPV adherence, psychological assessments, and caregiver feedback. Safety and feasibility outcomes such as recruitment, retention, and crossover rates will be tracked over two years. This research aims to provide evidence for a home-based NiPPV start that could reduce hospital stays and improve care for children with complex medical needs.
CONDITIONS
Brief Title
Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 17 years old
- Newly prescribed noninvasive positive pressure ventilation (NiPPV)
- Has tolerated an awake NiPPV trial
- Provides informed consent
You will not qualify if you...
- Cardiac disease with risk of hemodynamic instability during NiPPV initiation, such as cardiac dysfunction with ejection fraction below 45%, pulmonary hypertension with mean pulmonary artery pressure at or above 20 mmHg, or single ventricle condition
- High risk of complications with NiPPV as determined by the child’s physician, including pneumothorax and aspiration risk
- Severe sleep disordered breathing with peak CO2 at or above 60 mmHg or apnea-hypopnea index (AHI) of 30 or more per hour
- Participation in another research study that might affect NiPPV adherence
- Caregiver or participant not English speaking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive initiation of noninvasive positive pressure ventilation (NiPPV) either at home with telemonitoring or in-hospital polysomnography for setting titration and adjustment over time.
1 initiation visit and follow-up titration contacts at 1, 4, and 12 weeks
Duration - 1 day
Participants complete a final in-hospital polysomnography to assess and optimize NiPPV settings after 12 weeks of home or hospital initiation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
Research Team
R
Reshma Amin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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