Interface Selection for Adaptive Servo Ventilation

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: Central Sleep Apnea; ASV
• Intervention / Treatment: Device: Switch from oronasal to nasal mask during ASV treatment; Device: Switch from nasal to oronasal mask during ASV treatment

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Effect on respiratory events	Two nights

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Central
• Other Study ID Numbers: S57607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO