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Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea (ATMOS)

Primary Purpose

Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PAP titration at home
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fixed CPAP titration at home

APAP titration at home

Arm Description

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

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.

Outcomes

Primary Outcome Measures

CPAP adherence
Usage of the device (mean number of hours/day)

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2019
Last Updated
November 19, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04128930
Brief Title
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Acronym
ATMOS
Official Title
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixed CPAP titration at home
Arm Type
Experimental
Arm Description
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
Arm Title
APAP titration at home
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PAP titration at home
Intervention Description
Fixed CPAP or APAP titration at home
Primary Outcome Measure Information:
Title
CPAP adherence
Description
Usage of the device (mean number of hours/day)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effective pressure level
Description
Optimal pressure of CPAP therapy
Time Frame
2 weeks
Title
Residual apnea/hypopnea index
Description
Residual respiratory events during treatment with optimal CPAP pressure during PSG
Time Frame
2 weeks
Title
Mask leaks
Description
Objective leaks (L/min) during CPAP treatment
Time Frame
2 weeks
Title
Proportion of good titration
Description
Number of patients with residual AHI < 10 (objectivated with PSG)
Time Frame
2 weeks
Title
Residual device AHI
Description
Residual AHI as determined from device data
Time Frame
3 months
Title
Epworth Sleepiness Scale
Description
Daytime sleepiness (range: 0-24 - higher score means worse outcome)
Time Frame
3 months
Title
Blood pressure
Description
Blood pressure measurement
Time Frame
3 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality (range: 0-21 - higher score means worse outcome)
Time Frame
3 months
Title
36-Item Short Form Health Survey
Description
Quality of life (range: 0-100 - higher score means better outcome)
Time Frame
3 months
Title
Hospital contacts
Description
Number of contacts with the hospital
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dries Testelmans, MD, PhD
Phone
00 32 16 342522
Email
dries.testelmans@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

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