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Clinical Trials/NCT02919930
NCT02919930RecruitingNot Applicable

Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

Universitaire Ziekenhuizen KU Leuven2 sites in 1 country15 target enrollmentStarted: February 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
2
Primary Endpoint
Apnea/hypopnea index
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Apnea/hypopnea index

Time Frame: Two nights

Effect on respiratory events

Secondary Outcomes

  • Sleep architecture(Two nights)
  • Mask comfort VAS(Two nights)
  • Device leaks data(Two nights)
  • Sleep efficiency(Two nights)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Interface Selection for Adaptive Servo... | Clinical Trial