Positive Airway Pressure Program

Study Overview
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Brief Summary
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Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. Over the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence. This study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.

Official Title
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Positive Airway Pressure Program

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Behavioral: Adherence program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18years of age Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years Own a mobile phone, and has reliable mobile network coverage at their home. Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload. Exclusion Criteria: Contraindicated for CPAP therapy Medically unstable condition/diagnosis that is not yet under control Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study) Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive airway pressure adherence program<br>Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence. | Behavioral: Adherence program<br>* Participants will receive supportive messages while enrolled in the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Providing Feedback | Participants will be provided questionnaires so as to provide program feedback. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Provider Feedback | Healthcare providers will be provided questionaires so as to provide program feedback. | 1 month | 

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