A Study of a Sleep Health ‘App’ to Help First-Time Users of Positive Airway Pressure Therapy for Sleep Apnea
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-001960
- Rochester, Minnesota: 16-001960
Sponsor Protocol Number: 16-001960
About this study
The purpose of this study is to test the usefullness and initial effectiveness of an mHealth smartphone app to increase use of positive airway pressure (PAP) therapy in obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine.
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.
CLOSED FOR ENROLLMENT
Inclusion Criteria
- Age 21+ years
- Positive screen for moderate to severe obstructive sleep apnea using the Sleep Apnea Clinical Score screener
- Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea
- Currently uses an appropriate Apple (iOS7 or higher) or Android (2.3 or higher) smartphone device
- Is able to read and understand English
- Has been prescribed PAP treatment for obstructive sleep apnea
Exclusion Criteria
- Does not agree to be randomized
- Is currently participating in other lifestyle programs (e.g., active, formal weight loss program or research study; smoking cessation program, etc.)
- Has lost 10lb or 4.5kg over the past 4 weeks
- Has personal, health (e.g., stroke), cognitive (e.g., dementia) or psychological conditions that prevent participation
- Is pregnant, lactating, or trying to become pregnant
- Decide to use different 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
- Unwilling to consent for out-of-pocket costs
- Previous documented history of treatment/referral for claustrophobia
- Previous PAP use
- Other conditions determined by a sleep medicine team member that may interfere with full participation in the trial
- Planning to travel for more than seven consecutive nights during the trial
- Currently engaging in shiftwork defined as night shift or rotating day and night shifts
- Unwilling to have an in-person follow-up appointment at the Center for Sleep Medicine, Arizona
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Lois Krahn, M.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator John Park, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available