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
About this trial
This is an interventional supportive care trial for Sleep Apnea, Obstructive focused on measuring Continuous Positive Airway Pressure
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
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
NCT ID
NCT02331992
First Posted
January 4, 2015
Last Updated
February 4, 2018
Sponsor
Fisher and Paykel Healthcare
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
Learn more about this trial
Positive Airway Pressure Program
We'll reach out to this number within 24 hrs