Clinical trial for Sleep-Disordered Breathing
Official title Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
ClinicalTrials.gov ID: NCT05881031
What this study is testing
- What it's testing
- This study checks if it is safe and practical to set up a breathing machine at home. It compares this to the usual method of doing it in a hospital sleep lab.
- Who it's for
- The study is looking for children aged 5 to 17 who have complex medical needs and are starting to use a breathing machine for sleep.
- What's involved
- Participants will be randomly assigned to start the machine at home or in a hospital sleep lab. The team will monitor the process to ensure it works well and is safe.
- Time commitment
- The study involves the initial setup period for the breathing machine, which typically requires a one-night stay in the hospital or a home visit.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 215
You may be able to join if
- Age 5-17 years old
- Newly prescribed NiPPV
- Tolerated awake NiPPV trial
- Provides informed consent
You likely can't join if
- Cardiac disease at risk of hemodynamic instability with NiPPV initiation (eg cardiac dysfunction (ejection fraction \<45%), pulmonary hypertension...
- At high risk of complications with NiPPV in the opinion of the child's physician (eg pneumothorax and aspiration risk)
- Severe sleep disordered breathing with peak CO2 ≥ 60mmHg or apnea-hypopnea index (AHI)≥ 30/hr (AHI measures the number of respiratory events per hour)
- Participation in concurrent research study that may affect NiPPV adherence (proposed primary outcome of full study)
- Exclusion of study participants if the caregiver or participant is not English speaking
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 months to 215 months. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.