ASV, Central Sleep Apnea
Conditions
Brief summary
The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.
Interventions
DEVICESwitch from oronasal to nasal mask during ASV treatment
One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.
DEVICESwitch from nasal to oronasal mask during ASV treatment
One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with central sleep apnea, not responding to treatment with CPAP * Indication for treatment with ASV
Exclusion criteria
* Patients \< 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea/hypopnea index | Two nights | Effect on respiratory events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mask comfort VAS | Two nights | Subjective mask comfort |
| Device leaks data | Two nights | Evaluation of leaks (data of ASV device) |
| Sleep efficiency | Two nights | polysomnographic evaluation |
| Sleep architecture | Two nights | Polysomnographic evaluation of different sleep stages |
Countries
Belgium
Contacts
Primary ContactDries Testelmans, MD, PhD
Outcome results
None listed