Interface Selection for Adaptive Servo Ventilation

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: ASV; Central Sleep Apnea

Treatments: Device: Switch from nasal to oronasal mask during ASV treatment; Device: Switch from oronasal to nasal mask during ASV treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02919930

S57607

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with central sleep apnea, not responding to treatment with CPAP
• Indication for treatment with ASV

Exclusion criteria

• Patients < 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Oronasal - Nasal

Other group

Description:

Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night.

Treatment:

Device: Switch from oronasal to nasal mask during ASV treatment

Nasal - Oronasal

Other group

Description:

Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night.

Treatment:

Device: Switch from nasal to oronasal mask during ASV treatment