Sleep Apnea, Obstructive
Conditions
Keywords
Continuous Positive Airway Pressure
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.
Interventions
BEHAVIORALAdherence program
Participants will receive supportive messages while enrolled in the program.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Providing Feedback | 1 month | Participants will be provided questionnaires so as to provide program feedback. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Provider Feedback | 1 month | Healthcare providers will be provided questionaires so as to provide program feedback. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Adherence program: Participants will receive supportive messages while enrolled in the program. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Positive Airway Pressure Adherence Program |
|---|---|
| Age, Continuous | 44 years |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Participant Providing Feedback
Participants will be provided questionnaires so as to provide program feedback.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Airway Pressure Adherence Program | Participant Providing Feedback | 26 Participants |
Secondary
Healthcare Provider Feedback
Healthcare providers will be provided questionaires so as to provide program feedback.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Airway Pressure Adherence Program | Healthcare Provider Feedback | 2 Participants |