Clinical Trial: Interface Selection for Adaptive Servo Ventilation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

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 Summary:
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Apnea/hypopnea index [ Time Frame: Two nights ]

Effect on respiratory events

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Date Received: June 30, 2016
Date Started: February 2015
Date Completion: February 2018
Last Updated: September 27, 2016
Last Verified: June 2016