CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence

Philips

Status: Completed

Conditions: Adherence

Treatments: Behavioral: Education and feedback

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195531

PGI-BIG4-1331-MS

Details and patient eligibility

About

The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).

Full description

Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.

Enrollment: 169 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, ages 21-80 years
• Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.
• Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.
• CPAP treatment naïve

Exclusion criteria

• Inability to provide informed consent

• Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:

  • Unstable depressive disorder

  • Unstable anxiety disorder

  • Dementia

  • Unable to understand study information

  • Obesity Hypoventilation Syndrome

  • Central Sleep Apnea or Complex Sleep Apnea

  • Facial musculoskeletal disorder

    • Unwillingness or inability to use CPAP therapy
    • Unable to return for follow up appointment
    • Use of supplemental oxygen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

169 participants in 3 patient groups

Treatment

Active Comparator group

Description:

Participants will receive education and feedback tailored to the psychological profile of the receiving participant.

Treatment:

Behavioral: Education and feedback

Control Group

Active Comparator group

Description:

Participants will receive education inconsistent with their profile.

Treatment:

Behavioral: Education and feedback

Standard of care

No Intervention group

Description:

Participants will not receive education or feedback.