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Interface Selection for Adaptive Servo Ventilation

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ClinicalTrials.gov Identifier: NCT02919930
Recruitment Status : Unknown
Verified June 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Sleep Apnea ASV Device: Switch from oronasal to nasal mask during ASV treatment Device: Switch from nasal to oronasal mask during ASV treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018
Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Apnea/hypopnea index [ Time Frame: Two nights ]
    Effect on respiratory events


Secondary Outcome Measures :
  1. Mask comfort VAS [ Time Frame: Two nights ]
    Subjective mask comfort

  2. Device leaks data [ Time Frame: Two nights ]
    Evaluation of leaks (data of ASV device)

  3. Sleep efficiency [ Time Frame: Two nights ]
    polysomnographic evaluation

  4. Sleep architecture [ Time Frame: Two nights ]
    Polysomnographic evaluation of different sleep stages


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919930


Contacts
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Contact: Dries Testelmans, MD, PhD 00 32 16 342522 dries.testelmans@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Dries Testelmans, MD, PhD    00 32 16 342522    dries.testelmans@uzleuven.be   
Sub-Investigator: Bart Vrijsen, MSc, PT         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02919930    
Other Study ID Numbers: S57607
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Apnea, Central
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases