Interface Selection for Adaptive Servo Ventilation

Not Applicable

Recruiting

• Conditions: ASV; Central Sleep Apnea
• Interventions: Device: Switch from nasal to oronasal mask during ASV treatment; Device: Switch from oronasal to nasal mask during ASV treatment

• Registration Number: NCT02919930
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• Patients < 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal - Oronasal	Switch from nasal to oronasal mask during ASV treatment	Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night.
Oronasal - Nasal	Switch from oronasal to nasal mask during ASV treatment	Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night.

Primary Outcome Measures

Name	Time	Method
Apnea/hypopnea index	Two nights	Effect on respiratory events

Secondary Outcome Measures

Name	Time	Method
Sleep architecture	Two nights	Polysomnographic evaluation of different sleep stages
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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium