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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive airway pressure adherence program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence program | Behavioral | Participants will receive supportive messages while enrolled in the program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Providing Feedback | Participants will be provided questionnaires so as to provide program feedback. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Provider Feedback | Healthcare providers will be provided questionaires so as to provide program feedback. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamish Collie, MHlthSc | Fisher & Paykel Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Sleep Clinic | Huntsville | Alabama | 35801 | United States | ||
| IV Care & Respiratory |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Providing Feedback | Participants will be provided questionnaires so as to provide program feedback. | Posted | Count of Participants | Participants | 1 month |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher & Paykel Healthcare | +64 9 5740123 | cpaptrial@fphcare.co.nz |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Belleville |
| Illinois |
| 62223 |
| United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Healthcare Provider Feedback | Healthcare providers will be provided questionaires so as to provide program feedback. | Posted | Count of Participants | Participants | 1 month |
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| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
The PI agrees to supply the sponsor with any proposed publications or presentation. Any information that affect the sponsor IP, or information that is commercially sensitive, may be delayed, deleted or amended.
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |