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NCT Number: NCT02919930

Interface Selection for Adaptive Servo Ventilation

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.

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Key information

Conditions

Central Sleep Apnea ASV Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Bart Vrijsen, MSc, PT

SUB_INVESTIGATOR

Dries Testelmans, MD, PhD

CONTACT

[email protected]

00 32 16 342522

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients < 18 years old

Treatment and study plan

Switch from oronasal to nasal mask during ASV treatment

Device

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

Switch from nasal to oronasal mask during ASV treatment

Device

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

Primary outcomes

  1. Apnea/hypopnea index

    Time frame: Two nights

    Effect on respiratory events

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Dries Testelmans, MD, PhD

CONTACT

[email protected]

00 32 16 342522

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2016
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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