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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oronasal - Nasal | Other | Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night. |
|
| Nasal - Oronasal | Other | Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch from oronasal to nasal mask during ASV treatment | Device | One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea/hypopnea index | Effect on respiratory events | Two nights |
| Measure | Description | Time Frame |
|---|---|---|
| Mask comfort VAS | Subjective mask comfort | Two nights |
| Device leaks data | Evaluation of leaks (data of ASV device) | Two nights |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dries Testelmans, MD, PhD | Contact | 00 32 16 342522 | dries.testelmans@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Switch from nasal to oronasal mask during ASV treatment | Device | One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask. |
|
| Sleep efficiency | polysomnographic evaluation | Two nights |
| Sleep architecture | Polysomnographic evaluation of different sleep stages | Two nights |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |