N/A
N=34
Positive Airway Pressure Program
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02331992 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Participant Providing Feedback — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adherence program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Providing Feedback |
26 | — |
| SECONDARY Healthcare Provider Feedback |
2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02331992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.