Positive Airway Pressure Program

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Behavioral: Adherence program

• Registration Number: NCT02331992
• Lead Sponsor: Fisher and Paykel Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Study Start: 2015-02
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Results First Submitted: 2015-12-02
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-04
• Last Update Submitted: 2018-02-04
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive airway pressure adherence program	Adherence program	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.

Primary Outcome Measures

Name	Time	Method
Participant Providing Feedback	1 month	Participants will be provided questionnaires so as to provide program feedback.

Secondary Outcome Measures

Name	Time	Method
Healthcare Provider Feedback	1 month	Healthcare providers will be provided questionaires so as to provide program feedback.

Trial Locations

Locations (3)

Alabama Sleep Clinic; 🇺🇸 Huntsville, Alabama, United States

IV Care & Respiratory; 🇺🇸 Belleville, Illinois, United States

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States