Positive Airway Pressure Program

Fisher & Paykel Healthcare

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Behavioral: Adherence program

Study type: Interventional

Funder types: Industry

Identifiers

NCT02331992

CIA-146

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Positive airway pressure adherence program

Experimental group

Description:

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.

Treatment:

Behavioral: Adherence program