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Promoting the Use of CPAP Therapy Among OSA Patients

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP4HealthySleep system
Sponsored by
Sarah Alismail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pomona Valley Hospital Medical Center Adults and Children Sleep Disorders Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CPAP4HealthySleep: System 1 (ABAB)

CPAP4HealthySleep: System 2 (BABA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in CPAP usage
The average number of hours per week of CPAP usage.
CPAP compliance
Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2020
Last Updated
August 16, 2022
Sponsor
Sarah Alismail
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1. Study Identification

Unique Protocol Identification Number
NCT04372329
Brief Title
Promoting the Use of CPAP Therapy Among OSA Patients
Official Title
A Tailored Sleep Behavior Change Support System to Promote the Use of Continuous Positive Airway Pressure Therapy: Theorizing the Solution
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Alismail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP4HealthySleep: System 1 (ABAB)
Arm Type
Experimental
Arm Description
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.
Arm Title
CPAP4HealthySleep: System 2 (BABA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CPAP4HealthySleep system
Intervention Description
Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy
Primary Outcome Measure Information:
Title
Change in CPAP usage
Description
The average number of hours per week of CPAP usage.
Time Frame
During 19 weeks
Title
CPAP compliance
Description
Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.
Time Frame
19 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Alismail, MS, MPH
Organizational Affiliation
Claremont Graduate University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pomona Valley Hospital Medical Center Adults and Children Sleep Disorders Center
City
Claremont
State/Province
California
ZIP/Postal Code
91711
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Promoting the Use of CPAP Therapy Among OSA Patients

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