Promoting the Use of CPAP Therapy Among OSA Patients

NCT04372329 | Completed

• 1 other identifier: 3726
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in CPAP usage

  The average number of hours per week of CPAP usage.

  During 19 weeks

• CPAP compliance

  Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.

  19 weeks

Study Arms (2)

CPAP4HealthySleep: System 1 (ABAB)

EXPERIMENTAL

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.

Behavioral: CPAP4HealthySleep system

CPAP4HealthySleep: System 2 (BABA)

EXPERIMENTAL

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.

Behavioral: CPAP4HealthySleep system

Interventions

CPAP4HealthySleep system BEHAVIORAL

Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy

CPAP4HealthySleep: System 1 (ABAB); CPAP4HealthySleep: System 2 (BABA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of OSA
• Prescribed treatment of CPAP therapy
• Possession of a mobile phone that has multimedia messaging capabilities
• Capacity to consent.

You may not qualify if:

• Unable to speak and read English

Sponsors & Collaborators

• Sarah Alismail: lead

Study Sites (1)

Pomona Valley Hospital Medical Center Adults and Children Sleep Disorders Center

Claremont, California, 91711, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sarah Alismail, MS, MPH

  Claremont Graduate University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 4, 2020
• Study Start: July 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

US (1)