Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT04128930
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2019-10-14
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CPAP adherence	3 months	Usage of the device (mean number of hours/day)

Secondary Outcome Measures

Name	Time	Method
Proportion of good titration	2 weeks	Number of patients with residual AHI \< 10 (objectivated with PSG)
Epworth Sleepiness Scale	3 months	Daytime sleepiness (range: 0-24 - higher score means worse outcome)
Blood pressure	3 months	Blood pressure measurement
Hospital contacts	3 months	Number of contacts with the hospital
Mask leaks	2 weeks	Objective leaks (L/min) during CPAP treatment
Effective pressure level	2 weeks	Optimal pressure of CPAP therapy
Pittsburgh Sleep Quality Index (PSQI)	3 months	Sleep quality (range: 0-21 - higher score means worse outcome)
Residual apnea/hypopnea index	2 weeks	Residual respiratory events during treatment with optimal CPAP pressure during PSG
Residual device AHI	3 months	Residual AHI as determined from device data
36-Item Short Form Health Survey	3 months	Quality of life (range: 0-100 - higher score means better outcome)

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium