Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— ATMOS  

Official title:

Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128930
• Other study ID #: S62965
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• 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 aim of this trial is to compare two different ways of CPAP titration: CAP titration with fixed pressure vs. auto-titrating CPAP.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• PAP titration at home
Fixed CPAP or APAP titration at home

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