App-Based Optimization of Long-Term CPAP Adherence and Quality of Life

Overview

About this study

The purpose of this study is to conduct two optimization trials that test decision rules and adaptive algorithms programmed into the smartphone application SleepWell24 to optimize for early CPAP adoption to achieve > 6 hours/night for ≥ 6 nights/week of CPAP; and to optimize long-term health-related QoL and long-term CPAP maintenance over 6 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.
  • In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
  • Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who:
    • Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study;
    • Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance;
    • Are prescribed continuous or auto-titrated CPAP;
    • Agree to using a smartphone application and wearable wrist sensor; and
    • Speak and read English. 

Exclusion Criteria:

  • Exclusion Criteria are the same for both Aim 2 trials
    • Unwilling to complete study measures and engage with SleepWell24;
    • Refuse to not use the Fitbit application during the study trial;
    • Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions);
    • Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.);
    • Decide to use a different PAP device than ResMed Airsense 10;
    • Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night);
    • Daily opioid medication use at night;'
    • Unwilling to discontinue use of any current wearable sensor for the duration of the trial;
    • Previous documented history of treatment/referral for claustrophobia;
    • Previous CPAP use;
    • Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and
    • Currently pregnant, trying to conceive, or breastfeeding.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/22/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Morgenthaler, M.D.

Open for enrollment

Contact information:

Brandon Clapp

(507) 284-2122

Clapp.Brandon@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Umesh Goswami, M.B.B.S., M.D.

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
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CLS-20561902

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