Interface Selection for Adaptive Servo Ventilation

July 2, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Sub-Investigator:
          • Bart Vrijsen, MSc, PT
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oronasal - Nasal
Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night.
Device: 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.
Other: Nasal - Oronasal
Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea/hypopnea index
Time Frame: Two nights
Effect on respiratory events
Two nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mask comfort VAS
Time Frame: Two nights
Subjective mask comfort
Two nights
Device leaks data
Time Frame: Two nights
Evaluation of leaks (data of ASV device)
Two nights
Sleep efficiency
Time Frame: Two nights
polysomnographic evaluation
Two nights
Sleep architecture
Time Frame: Two nights
Polysomnographic evaluation of different sleep stages
Two nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimated)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S57607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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