Interface Selection for Adaptive Servo Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with central sleep apnea, not responding to treatment with CPAP
Indication for treatment with ASV
Disqualifiers
Patients < 18 years old
Trial design
Design model
Crossover
Treatments tested in this trial
Switch from oronasal to nasal mask during ASV treatment
DeviceOne night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.
Switch from nasal to oronasal mask during ASV treatment
DeviceOne night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Oronasal - NasalOther 1 intervention
Group B: Nasal - OronasalOther 1 intervention
Trial outcomes
Primary outcomes
1
Apnea/hypopnea index
Effect on respiratory events
Time frame
Two nightsSecondary outcomes
1
Mask comfort VAS
Subjective mask comfort
Time frame
Two nights2
Device leaks data
Evaluation of leaks (data of ASV device)
Time frame
Two nights3
Sleep efficiency
polysomnographic evaluation
Time frame
Two nights4
Sleep architecture
Polysomnographic evaluation of different sleep stages
Time frame
Two nightsSponsors and contacts
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Source ClinicalTrials.gov