Home initiation of breathing support for children with complex medical needs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and safety of starting noninvasive positive pressure ventilation (NiPPV) for children with medical complexity (CMC) in their home environment, rather than in a hospital setting. The research involves randomly assigning participants to either home initiation of NiPPV with remote telemonitoring or the standard in-hospital polysomnography (PSG) method. By assessing the effectiveness of this innovative approach, the study aims to improve adherence to NiPPV and enhance the quality of life for CMC. The study focuses on children aged 5-17 years who are newly prescribed NiPPV and have tolerated an awake trial of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 5-17 years old
2. Newly prescribed NiPPV
3. Tolerated awake NiPPV trial
4. Provides informed consent

Exclusion Criteria:

1. 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)
2. At high risk of complications with NiPPV in the opinion of the child's physician (eg pneumothorax and aspiration risk)
3. Severe sleep disordered breathing with peak CO2 ≥ 60mmHg or apnea-hypopnea index (AHI)≥ 30/hr (AHI measures the number of respiratory events per hour)
4. Participation in concurrent research study that may affect NiPPV adherence (proposed primary outcome of full study)
5. Exclusion of study participants if the caregiver or participant is not English speaking

Where it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Reshma Amin, MD — The Hospital for Sick Children
• Study coordinator: Reshma Amin, MD
• Email: Reshma.Amin@sickkids.ca
• Phone: (416) 813-7654

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Respiratory progression in adults with Duchenne muscular dystrophy: a long-term observational study

  This study tests how respiratory function changes over three years in adults with genetically confirmed Duchenne muscular dystrophy.

  Recruiting at 13 sites Istituto Giannina Gaslini · Bologna and 12 other locations · NCT07879989

• Tonsillectomy Added to Hypoglossal Nerve Stimulation for OSA with Lateral Wall Collapse

  In adults with obstructive sleep apnea and side-wide airway collapse, this study tests whether adding tonsil removal to hypoglossal nerve stimulation helps more than hypoglossal nerve stimulation alone.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07724938

• Combined upper-airway electrical stimulation with a drug combo for sleep apnea

  This study tests whether adding a drug mix called AtoOxy to an existing hypoglossal nerve stimulation device helps people with sleep apnea sleep better.

  Recruiting Phase 1/2 Brigham and Women's Hospital · Boston, Massachusetts · NCT07577661

• Central Sleep Apnea in Heart Failure: How Mechanisms May Guide Treatment

  This study tests whether combining positive airway pressure with a medication (trazodone) or oxygen can reduce central sleep apnea in Veterans with heart failure and ensure better breathing during sleep.

  Recruiting Phase 4 VA Office of Research and Development · Detroit, Michigan · NCT07210606

• Comparing two methods to help children with sleep apnea

  This study is testing whether a special mouth device can help children with sleep apnea sleep better compared to just using nasal care before their surgery.

  Recruiting Université de Montréal · Montreal, Quebec · NCT06634264

• Comparing pain control methods after tonsil surgery in children

  This study is testing whether long-lasting pain medicine like methadone works better than short-lasting options like fentanyl and hydromorphone for controlling pain in kids and teens after tonsil surgery.

  Recruiting Phase 4 Duke University · Durham, North Carolina · NCT06576830

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.