Interface Selection for Adaptive Servo Ventilation

Central Sleep Apnea Clinical Trial

Official title:

Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02919930
• Other study ID #: S57607
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 2022

Study information

• Verified date: April 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Dries Testelmans, MD, PhD
• Phone: 00 32 16 342522
• Email: dries.testelmans[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Indication for treatment with ASV

Exclusion Criteria:

• Patients < 18 years old

Related Conditions & MeSH terms

• ASV
• Central Sleep Apnea
• Sleep Apnea, Central

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/hypopnea index	Effect on respiratory events	Two nights
Secondary	Mask comfort VAS	Subjective mask comfort	Two nights
Secondary	Device leaks data	Evaluation of leaks (data of ASV device)	Two nights
Secondary	Sleep efficiency	polysomnographic evaluation	Two nights
Secondary	Sleep architecture	Polysomnographic evaluation of different sleep stages	Two nights