Interface Selection for Adaptive Servo Ventilation

NCT02919930 | Recruiting

• 1 other identifier: S57607
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Sleep Apnea; ASV

Outcome Measures

Primary Outcomes (1)

• Apnea/hypopnea index

  Effect on respiratory events

  Two nights

Secondary Outcomes (4)

• Mask comfort VAS

  Two nights

• Device leaks data

  Two nights

• Sleep efficiency

  Two nights

• Sleep architecture

  Two nights

Study Arms (2)

Oronasal - Nasal

OTHER

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

Nasal - Oronasal

OTHER

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

Interventions

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.

Oronasal - Nasal

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.

Nasal - Oronasal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients \< 18 years old

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dries Testelmans, MD, PhD

CONTACT

00 32 16 342522; dries.testelmans@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: September 30, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)