Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea (ATMOS)

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

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

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: PAP titration at home

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 Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Dries Testelmans, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: PAP titration at home; Fixed CPAP or APAP titration at home
ACTIVE_COMPARATOR: 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.	Device: PAP titration at home; Fixed CPAP or APAP titration at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP adherence	Usage of the device (mean number of hours/day)	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dries Testelmans, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: S62965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No