Sleep Apnea, Obstructive
Conditions
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.
Interventions
DEVICEPAP titration at home
Fixed CPAP or APAP titration at home
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP adherence | 3 months | Usage of the device (mean number of hours/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual apnea/hypopnea index | 2 weeks | Residual respiratory events during treatment with optimal CPAP pressure during PSG |
| Mask leaks | 2 weeks | Objective leaks (L/min) during CPAP treatment |
| Proportion of good titration | 2 weeks | Number of patients with residual AHI \< 10 (objectivated with PSG) |
| Residual device AHI | 3 months | Residual AHI as determined from device data |
| Effective pressure level | 2 weeks | Optimal pressure of CPAP therapy |
| Blood pressure | 3 months | Blood pressure measurement |
| Pittsburgh Sleep Quality Index (PSQI) | 3 months | Sleep quality (range: 0-21 - higher score means worse outcome) |
| 36-Item Short Form Health Survey | 3 months | Quality of life (range: 0-100 - higher score means better outcome) |
| Hospital contacts | 3 months | Number of contacts with the hospital |
| Epworth Sleepiness Scale | 3 months | Daytime sleepiness (range: 0-24 - higher score means worse outcome) |
Countries
Belgium
Outcome results
None listed