Comparing nasal and oronasal masks for treating central sleep apnea
Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
This study is testing whether using a nasal mask or an oronasal mask helps people with central sleep apnea sleep better while using a special breathing machine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT02919930 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of different mask interfaces, specifically nasal and oronasal, on sleep efficiency and architecture in patients undergoing Adaptive Servo Ventilation (ASV) for central sleep apnea. Participants will be randomly assigned to use either a nasal mask or an oronasal mask on alternating nights to determine which interface provides better outcomes. The findings are expected to inform clinical practices by establishing guidelines for selecting the most effective mask for ASV treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with central sleep apnea who have not responded to CPAP treatment and are indicated for ASV.
Not a fit: Patients under 18 years old will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with central sleep apnea by optimizing mask selection during ASV therapy.
How similar studies have performed: While the specific approach of comparing nasal and oronasal interfaces in ASV treatment may be novel, similar studies have shown the importance of interface selection in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with central sleep apnea, not responding to treatment with CPAP * Indication for treatment with ASV Exclusion Criteria: * Patients \< 18 years old
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Dries Testelmans, MD, PhD
- Email: dries.testelmans@uzleuven.be
- Phone: 00 32 16 342522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.