Obstructive sleep apnea sleep apnea
Conditions
Interventions
Participants will receive two types of patient-specific CPAP masks (fully customized &
add-on mask) that are designed based on individual facial anatomy. The patient-specific masks will be used in combination with the participant’s regular CPAP device. No changes will be made to CPAP pr
Sponsors
Medisch Spectrum Twente (MST)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Established obstructive sleep apnea (apnea-hypopnea index of 5/hour or more on poly(somno)graphy)- Patients with an ill-fitting CPAP mask, determined by the treating healthcare professional. For example, due to leakage or discomfort- 18 years or older at time of inclusion
Exclusion criteria
Exclusion criteria: - Unable or unwilling to sleep with a full-face mask, for example due to claustrophobia. - Patients with a contraindication to ResMed full face masks (i.e. patients with an active implantable medical device and/or metallic implants/objects containing ferromagnetic material) due to possible magnetic interference of the magnetic straps that are present on the mask. - Patients who used CPAP therapy less than 5 nights per week in the last 2 months on average - Patients with known contact dermatitis due to CPAP mask usage - Patients with known allergy to silicone - Patients with open skin wounds at or near the CPAP mask area at time of inclusion - Cognitive impairments that causes the patient to be unable to understand the research purpose and/or accompanying instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the general satisfaction of the patient-specific CPAP masks compared to a standard commercially full-face mask. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective improvement in mask comfort, measured through the WMFQ (comfort while awake), SMCQ (comfort while sleeping), and LAPQ (more specific questions about skin pressure points and air leakage). Subjective experiences with the use of the patient-specific masks, measured with the OME questionnaire. Reduction in objective air leakage (measured through CPAP readouts) and potential changes in leakage distribution (thermal imaging) Reduction in skin pressure points, measured with the skin pressure sensors | — |
Countries
Netherlands
Contacts
Public ContactT. Heuker of Hoek
Medisch Spectrum Twente (MST)
Outcome results
None listed