Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

NCT ID: NCT04128930

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2021-12-31

Brief Summary

The aim of this trial is to compare two different ways of CPAP titration:

CAP titration with fixed pressure vs. auto-titrating CPAP.

Detailed Description

Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed CPAP titration at home

Patients will start CPAP treatment with a pressure that is calculated by the following formula (predicted pressure = (0.13 x BMI) + (0.16x neck circumference in cm) + (0.04 x AHI)) with a maximal pressure of 10 cmH2O. After 3 nights and after 7 nights, CPAP data will be remotely evaluated and pressure will be adapted based on the following rules:

• After 3 nights: median obstructive AHI<5/h: decrease pressure with 2 cmH2O; median obstructive AHI>5/h: increase with 2cmH2O
• After 7 nights: median obstructive AHI>5/h of 4 nights after last adaptation: increase with 2 cmH2O

Group Type: EXPERIMENTAL

PAP titration at home

Intervention Type: DEVICE

Fixed CPAP or APAP titration at home

APAP titration at home

Patients will start CPAP treatment with an auto-adjusting CPAP device with pressure levels between 4 and 12 cmH2O. After 7 nights of titration, the optimal pressure will be determined by analyzing the median of the nightly pressure that included 95% of the periods (percentile 95). CPAP treatment will be continued with this fixed optimal pressure.

Group Type: ACTIVE_COMPARATOR

PAP titration at home

Intervention Type: DEVICE

Fixed CPAP or APAP titration at home

Interventions

PAP titration at home

Fixed CPAP or APAP titration at home

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• moderate OSA (obstructive AHI 15-30/u on initial PSG)

Exclusion Criteria

• Presence of hypoventilation
• Presence of central sleep apnea (central AHI ≥ 15)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dries Testelmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S62965

Identifier Type: -

Identifier Source: org_study_id