Personal Therapy Comfort Settings Pilot Clinical Study

Study Overview
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Brief Summary
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350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment. User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group). Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance

Official Title
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Personal Therapy Comfort Settings Pilot Clinical Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to give written informed consent Patients who can read and comprehend English Patients who are ≥ 18 years of age Patients newly diagnosed with OSA and indicated for CPAP therapy. Exclusion Criteria: Patients who have previously used PAP therapy Patients who require a bilevel device Patients who are or may be pregnant * Patients who are unable to attend follow up appointments Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury Patients believed to be unsuitable for inclusion by the researcher

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Default comfort settings<br>Comfort settings will be set to default (out of the box setttings) | Device: continuous positive airway pressure (CPAP)<br>* CPAP comfort settings will be modified in the active group to be personalized to each participant<br>|
| Experimental: Personalized Therapy Comfort Settings<br>Comfort settings will be personalized to each user | Device: continuous positive airway pressure (CPAP)<br>* CPAP comfort settings will be modified in the active group to be personalized to each participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of treatment continuance between the control group and active treatment group. | Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment. | 4 weeks after commencement of CPAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of compliance between the control group and active treatment group | Usage will be compared between the two groups | 4 weeks after commencement of CPAP | 
| Treatment efficacy | Residual Apnea-hypopnea index will be compared between the two groups | 4 weeks after commencement of CPAP | 
| Mask leak | Mask leak will be compared between the two groups | 4 weeks after commencement of CPAP | 
| Settings changes | Number of comfort settings changes will be compared between the two groups | 4 weeks after commencement of CPAP | 
| Ad hoc contacts | Number of ad hoc contacts between participants and clinicians will be compared between the two groups | 4 weeks after commencement of CPAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure