Interface Selection for Adaptive Servo Ventilation

NCT ID: NCT02919930

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Central Sleep Apnea ASV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oronasal - Nasal

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

Group Type OTHER

Switch from oronasal to nasal mask during ASV treatment

Intervention Type DEVICE

One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.

Nasal - Oronasal

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

Group Type OTHER

Switch from nasal to oronasal mask during ASV treatment

Intervention Type DEVICE

One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.

Interventions

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Switch from oronasal to nasal mask during ASV treatment

One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.

Intervention Type DEVICE

Switch from nasal to oronasal mask during ASV treatment

One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dries Testelmans, MD, PhD

Role: CONTACT

00 32 16 342522

Facility Contacts

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Dries Testelmans, MD, PhD

Role: primary

00 32 16 342522

Other Identifiers

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S57607

Identifier Type: -

Identifier Source: org_study_id

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