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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

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

Group Type ACTIVE_COMPARATOR

Education and feedback

Intervention Type BEHAVIORAL

The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Control Group

Participants will receive education inconsistent with their profile.

Group Type ACTIVE_COMPARATOR

Education and feedback

Intervention Type BEHAVIORAL

The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Standard of care

Participants will not receive education or feedback.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education and feedback

The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Intervention Type BEHAVIORAL

Other Intervention Names

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Education Motivational Enhancement technique

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No