Positive Airway Pressure Program

NCT ID: NCT02331992

Last Updated: 2018-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

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.

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Positive airway pressure 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.

Group Type EXPERIMENTAL

Adherence program

Intervention Type BEHAVIORAL

Participants will receive supportive messages while enrolled in the program.

Interventions

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Adherence program

Participants will receive supportive messages while enrolled in the program.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamish Collie, MHlthSc

Role: STUDY_CHAIR

Fisher & Paykel Healthcare

Locations

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Alabama Sleep Clinic

Huntsville, Alabama, United States

Site Status

IV Care & Respiratory

Belleville, Illinois, United States

Site Status

SleepMed of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CIA-146

Identifier Type: -

Identifier Source: org_study_id

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