- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372329
Promoting the Use of CPAP Therapy Among OSA Patients
August 16, 2022 updated by: Sarah Alismail
A Tailored Sleep Behavior Change Support System to Promote the Use of Continuous Positive Airway Pressure Therapy: Theorizing the Solution
Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA.
However, up to 50% of patients who accept using CPAP therapy fail to adhere to it.
This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients.
The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Claremont, California, United States, 91711
- Pomona Valley Hospital Medical Center Adults and Children Sleep Disorders Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of OSA
- Prescribed treatment of CPAP therapy
- Possession of a mobile phone that has multimedia messaging capabilities
- Capacity to consent.
Exclusion Criteria:
- Unable to speak and read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPAP4HealthySleep: System 1 (ABAB)
Participants in this group will first receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A).
Next, they will receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B), re-introduction of type A for another two weeks, followed by re-introduction of type B for two weeks.
|
Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy
|
Experimental: CPAP4HealthySleep: System 2 (BABA)
Participants in this group will first receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B).
Next, they will receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A), re-introduction of type B for another two weeks, followed by re-introduction of type A for two weeks.
|
Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in CPAP usage
Time Frame: During 19 weeks
|
The average number of hours per week of CPAP usage.
|
During 19 weeks
|
CPAP compliance
Time Frame: 19 weeks
|
Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.
|
19 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Alismail, MS, MPH, Claremont Graduate University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
April 25, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
August 18, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3726
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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