Overview

This trial is active, not recruiting.

Condition sleep apnea, obstructive
Treatment adherence program
Sponsor Fisher and Paykel Healthcare
Start date February 2015
End date July 2015
Trial size 30 participants
Trial identifier NCT02331992, CIA-146

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
adherence program
Participants will receive supportive messages while enrolled in the program.

Primary Outcomes

Measure
Participant feedback
time frame: 1 month

Secondary Outcomes

Measure
Healthcare provider feedback
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Positive Airway Pressure Program
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Fisher and Paykel Healthcare.