Positive Airway Pressure Program
1 other identifier
interventional
34
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
October 29, 2018
CompletedOctober 29, 2018
February 1, 2018
5 months
January 4, 2015
December 2, 2015
February 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant Providing Feedback
Participants will be provided questionnaires so as to provide program feedback.
1 month
Secondary Outcomes (1)
Healthcare Provider Feedback
1 month
Study Arms (1)
Positive airway pressure adherence program
EXPERIMENTALParticipants 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.
Interventions
Participants will receive supportive messages while enrolled in the program.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Alabama Sleep Clinic
Huntsville, Alabama, 35801, United States
IV Care & Respiratory
Belleville, Illinois, 62223, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Scientist
- Organization
- Fisher & Paykel Healthcare
Study Officials
- STUDY CHAIR
Hamish Collie, MHlthSc
Fisher & Paykel Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2015
First Posted
January 6, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
October 29, 2018
Results First Posted
October 29, 2018
Record last verified: 2018-02