Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity (NCT05881031)
Single Site Feasibility and Safety Study of Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
🩺 Plain-English Summary (8th-Grade Level)
Children with medical complexity (CMC) often have trouble breathing at night and need to use a breathing machine. This breathing machine is called noninvasive positive pressure ventilation (NiPPV). The use of NiPPV has been shown to improve quality of life and survival in children. Before it is used, NiPPV must first be tested to see what the correct 'machine settings' are for each child. This is usually done in the sleep laboratory at the hospital during a one-night stay. However, sleep studies in the hospital are disruptive and hard for CMC and their families because of the new environment and limited access to the equipment, supplies, comfort items and the routine their child has at home. Patients and families would prefer to start NiPPV at home but there needs to be more research on this to make sure it is possible and safe. This study will evaluate a new model of care to start NiPPV in the home. CMC aged 5-17 years old and starting NiPPV will be assigned at random, like a coin toss, to start NiPPV in the home or to start NiPPV in the sleep laboratory. The investigators will assess the feasibility and safety of the two ways to start NiPPV. This study will be the first step towards developing a study to evaluate if home NiPPV starts are effective. Starting NiPPV at home has the potential to improve the use of NiPPV (ie early adherence predicts long-term use) resulting in both medical benefits as well as improved quality of life for CMC and their families.
Who can join: Review the eligibility criteria below.
Location: The Hospital for Sick Children — Toronto, Ontario
Age range: 60 Months to 215 Months
🧪 Interventions in This Study
- Home Initiation of NiPPV (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The Hospital for Sick Children — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 813-7654
Email: Reshma.Amin@sickkids.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Sleep-Disordered Breathing
- Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor — Chardon, Ohio
- Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy — Murrieta, California
Explore by condition: All Sleep-Disordered Breathing clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.