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Interface Selection for Adaptive Servo Ventilation

Primary Purpose

Central Sleep Apnea, ASV

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Switch from oronasal to nasal mask during ASV treatment
Switch from nasal to oronasal mask during ASV treatment
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Oronasal - Nasal

Nasal - Oronasal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Apnea/hypopnea index
Effect on respiratory events

Secondary Outcome Measures

Mask comfort VAS
Subjective mask comfort
Device leaks data
Evaluation of leaks (data of ASV device)
Sleep efficiency
polysomnographic evaluation
Sleep architecture
Polysomnographic evaluation of different sleep stages

Full Information

First Posted
June 30, 2016
Last Updated
April 27, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02919930
Brief Title
Interface Selection for Adaptive Servo Ventilation
Official Title
Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Sleep Apnea, ASV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oronasal - Nasal
Arm Type
Other
Arm Description
Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night.
Arm Title
Nasal - Oronasal
Arm Type
Other
Arm Description
Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night.
Intervention Type
Device
Intervention Name(s)
Switch from oronasal to nasal mask during ASV treatment
Intervention Description
One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.
Intervention Type
Device
Intervention Name(s)
Switch from nasal to oronasal mask during ASV treatment
Intervention Description
One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.
Primary Outcome Measure Information:
Title
Apnea/hypopnea index
Description
Effect on respiratory events
Time Frame
Two nights
Secondary Outcome Measure Information:
Title
Mask comfort VAS
Description
Subjective mask comfort
Time Frame
Two nights
Title
Device leaks data
Description
Evaluation of leaks (data of ASV device)
Time Frame
Two nights
Title
Sleep efficiency
Description
polysomnographic evaluation
Time Frame
Two nights
Title
Sleep architecture
Description
Polysomnographic evaluation of different sleep stages
Time Frame
Two nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with central sleep apnea, not responding to treatment with CPAP Indication for treatment with ASV Exclusion Criteria: Patients < 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dries Testelmans, MD, PhD
Phone
00 32 16 342522
Email
dries.testelmans@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD, PhD
Phone
00 32 16 342522
Email
dries.testelmans@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Bart Vrijsen, MSc, PT

12. IPD Sharing Statement

Plan to Share IPD
No

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Interface Selection for Adaptive Servo Ventilation

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