Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: PAP titration at home


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed CPAP titration at home<br>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<br>* Fixed CPAP or APAP titration at home<br>|
| Active Comparator: APAP titration at home<br>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<br>* Fixed CPAP or APAP titration at home<br>|

What is the study measuring?
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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 |