Actively Recruiting
Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of interfaces used during Adaptive Servo Ventilation (ASV) treatment for patients with central sleep apnea who do not respond to CPAP therapy. The study aims to see how nasal and oronasal masks affect sleep quality, including sleep efficiency and architecture. This information could help doctors choose the best mask for patients from the start of treatment. Participants are randomly assigned to one of two groups. One group uses an oronasal mask the first night and a nasal mask the second night during polysomnography, while the other group uses a nasal mask first followed by an oronasal mask. Each participant experiences both types of masks over two nights under controlled conditions. During the study, researchers measure the apnea/hypopnea index, mask comfort using a visual scale, device leak data, sleep efficiency, and sleep architecture over the two nights. These measurements help evaluate how the different interfaces affect treatment and sleep. Participants' involvement includes two nights of monitored sleep and mask use, with the study expected to conclude by January 2025.
CONDITIONS
Brief Title
Interface Selection for Adaptive Servo Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with central sleep apnea, not responding to treatment with CPAP
- Indication for treatment with ASV
- Adults aged 18 years or older
You will not qualify if you...
- Patients younger than 18 years old
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.
Duration - 2 nights
Participants receive adaptive servo ventilation (ASV) treatment with two different interfaces in a randomized order over two nights.
2 overnight visits (in-person)
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
D
Dries Testelmans, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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