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Positive Airway Pressure Program

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence program
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Apnea, Obstructive focused on measuring Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alabama Sleep Clinic
  • IV Care & Respiratory
  • SleepMed of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive airway pressure adherence program

Arm 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.

Outcomes

Primary Outcome Measures

Participant Providing Feedback
Participants will be provided questionnaires so as to provide program feedback.

Secondary Outcome Measures

Healthcare Provider Feedback
Healthcare providers will be provided questionaires so as to provide program feedback.

Full Information

First Posted
January 4, 2015
Last Updated
February 4, 2018
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02331992
Brief Title
Positive Airway Pressure Program
Official Title
Positive Airway Pressure Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive airway pressure adherence program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Adherence program
Intervention Description
Participants will receive supportive messages while enrolled in the program.
Primary Outcome Measure Information:
Title
Participant Providing Feedback
Description
Participants will be provided questionnaires so as to provide program feedback.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Healthcare Provider Feedback
Description
Healthcare providers will be provided questionaires so as to provide program feedback.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamish Collie, MHlthSc
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Sleep Clinic
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
IV Care & Respiratory
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62223
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

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Positive Airway Pressure Program

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