Obstructive Sleep Apnea of AdultNCT03156283
SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
A study testing SleepWell24 Application in people with Obstructive Sleep Apnea of Adult, run by Arizona State University at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and "gold standard" for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- SleepWell24 Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to severe obstructive sleep apnea diagnosed through clinical diagnostic testing and laboratory or home-based sleep study
- current use of appropriate Apple (iOS7 or higher) or Android (2.3 or higher) smartphone device
- Be able to read, write, and understand English
- Prescribed positive airway pressure therapy for obstructive sleep apnea
Who cannot join
- Do not agree to be randomized
- Currently participating in other lifestyle change programs
- Personal, health, cognitive, or psychological conditions that prevent full participation
- Pregnant, lactating, or trying to become pregnant
- Prescribed high-dose benzodiazepines
- Daily opioid medication use at night
Show all 12Show fewer
- Unwilling to discontinue use of any current wearable sensor for the duration of the trial
- Unwilling to consent for out-of-pocket costs
- Previous treatment/referral for claustrophobia
- Previous Positive airway pressure therapy use
- Planning to travel for more than seven consecutive nights during the trial
- Currently engaging in shiftwork
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and "gold standard" for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP adherence programs do not address the self-management skills and strategies that promote adherence and are often too costly and complex to integrate into overburdened clinical environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical activity), which have promise to improve OSA symptoms and PAP adherence. The investigators have previously developed and successfully tested BeWell24, a multicomponent smartphone "app" that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical activity behaviors. The investigators will enhance this app to create SleepWell24. Enhancements will include: (1) specific behavior change strategies from the evidence-based Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange of patient data to facilitate patient-provider communication on treatment progress; and (3) real-time feedback via wireless integration with a consumer-based PAP machine and wearable sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared to a usual care control group. The investigators will conduct a pilot randomized controlled trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days post-PAP prescription. The investigators will track recruitment/retention rates, app usage statistics, and measures of treatment satisfaction. The investigators will objectively measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP usage compared to the usual care group. In an exploratory fashion, the investigators will also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime sleepiness, cognitive impairment, and health-related quality of life) and evaluate social cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.
Read the detailed description
This exploratory study will test the feasibility and initial efficacy of a mobile health smartphone intervention to increase adherence to positive airway pressure (PAP) therapy in newly diagnosed obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics. This app, called SleepWell24, will include PAP adherence behavior change strategies (drawn from the evidence-based Sleep Apnea Self-Management Program), cloud-based linkages to a consumer-based PAP machine and wearable sensor that provides nightly feedback on PAP adherence and sleep and activity metrics, and a component to enhance patient-provider communication. The investigators will embed SleepWell24 within usual patient care at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics for app design/development, patient recruitment, and treatment feasibility/satisfaction. This design will ensure the best opportunity for clinical adoption. The primary aims are:
Aim 1: Determine the feasibility and acceptability of SleepWell24 from patient and provider perspectives.
Aim 2: Determine the extent to which SleepWell24 improves PAP adherence over the first 60 days of use relative to usual care.
As an exploratory aim the investigators will explore the effect of SleepWell24 on treatment outcomes (weight, daytime sleepiness, cognitive performance, health-related quality of life) and putative social cognitive and behavioral mediators of PAP adherence (e.g., self-efficacy, sleep quality, sedentary behavior, physical activity).
The investigators will test the feasibility, acceptability, initial efficacy and outcomes of SleepWell24 compared to usual care during the first 60 days of PAP use among 94 patients newly diagnosed with obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- SleepWell24 Application, Usual Care Plus Activity Monitor
- Keywords
- smartphone, obstructive sleep apnea, adherence
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepWell24 ApplicationBehavioural
An evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy
Usual Care Plus Activity MonitorOther
Participants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.
| Study group | Role | What they receive |
|---|---|---|
| SleepWell24 Application | Experimental | A mobile health smartphone application based on evidence-based health behavior change theory and interventions to promote adherence to positive airway pressure therapy Receives: Behavioral: SleepWell24 Application |
| Usual Care Plus Activity Monitor | Other | Per usual clinical care standards within the Center for Sleep Medicine at Mayo Clinic Arizona, all patients will receive instructions/education on positive airway pressure (PAP) use, multiple mask fittings, encouragement to use PAP every night, and staff is available in the event of problems. Control patients will also receive a wearable activity monitor to use during the study. The wearable sensor will be used to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app. Receives: Other: Usual Care Plus Activity Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and Retention
numbers recruited and retained over the course of the trial
Measured: Duration of the trial (~60 days)
SleepWell24 application usage
objective metrics of smartphone application usage by intervention group
Measured: Duration of the trial (~60 days)
Treatment acceptability/satisfaction
Intervention acceptability questionnaire for both groups
Measured: Baseline vs. Day 60 of trial
Positive airway pressure therapy use
How many hours per night therapy was used throughout the trial
Measured: Duration of the trial (~60 days)
Secondary outcomes (5)
Body Mass Index
body mass index according to weight and height
Measured: Baseline and follow-up visit between days 31 and 60
Daytime Sleepiness
Epworth Sleepiness Scale
Measured: Baseline, Day 30, Day 60 of trial
Cognitive functioning
Neurocognitive battery
Measured: Baseline and follow-up visit between days 31 and 60
Global Quality of Life due to physical and mental health via the Patient Reported Outcomes Measurement Information System Global Health Scale
The investigators will measure quality of life in general as informed by current physical and mental health using the quality of life in general as informed by current physical and mental health using the Patient Reported Outcomes Measurement Information System Global Health Scale. This Scale measures an individual's physical, mental, and social health, in general. This measure produces 2 scores: Physical Health and Mental Health. Summed raw scores are converted to T-score values with a mean of 50 and a standard deviation of 10. A higher T score indicates better Global Physical or Mental Health depending on the subscale used.
Measured: Baseline, Day 30, Day 60 of trial
Sleep Apnea-Specific Quality of Life
The investigators will measure functional outcomes of sleep apnea with the Functional Outcomes of Sleep Questionnaire, which measures how difficult it is to carry out certain activities because of daytime sleepiness due to sleep apnea. It is a 10-item questionnaire representing 5 subscales. To obtain the total score, a mean-weighted item score is first computed for subscales with more than one item. Then the total score is derived by calculating the mean of the subscale scores and multiplying that mean by 5. Higher total scores indicate less difficulty with sleepiness due to sleep apnea affecting daytime activities. Scale ranges from 0 to 40.
Measured: Baseline, Day 30, Day 60 of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Nov 2017
- Primary completion31 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Mayo Clinic
- Responsible party
- Principal investigator, Megan Petrov, Arizona State University
- Investigators
- Megan E Petrov, PhD, Principal investigator, Arizona State UniversityMatthew Buman, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156283
- Sponsor's protocol ID
- 5R21NR016046-02
- Other IDs
- R21NR016046
- Status last verified
- Aug 2019
- First submitted
- 27 Apr 2017
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrov ME, Epstein DR, Krahn L, Todd M, Park JG, St Louis EK, Morgenthaler TI, Hoffmann CM, Hasanaj K, Hollingshead K, Yu TY, Buman MP. SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial. Behav Sleep Med. 2024 Jul-Aug;22(4):420-432. doi: 10.1080/15402002.2023.2289442. Epub 2023 Nov 30.
PubMed 38032115
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
- ClinicalTrials.gov ID
- NCT03156283
- Acronym / sponsor ID
- 5R21NR016046-02
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- smartphone, obstructive sleep apnea, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Mayo Clinic
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and "gold standard" for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP adherence programs do not address the self-management skills and strategies that promote adherence and are often too costly and complex to integrate into overburdened clinical environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical activity), which have promise to improve OSA symptoms and PAP adherence. The investigators have previously developed and successfully tested BeWell24, a multicomponent smartphone "app" that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical activity behaviors. The investigators will enhance this app to create SleepWell24. Enhancements will include: (1) specific behavior change strategies from the evidence-based Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange of patient data to facilitate patient-provider communication on treatment progress; and (3) real-time feedback via wireless integration with a consumer-based PAP machine and wearable sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared to a usual care control group. The investigators will conduct a pilot randomized controlled trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days post-PAP prescription. The investigators will track recruitment/retention rates, app usage statistics, and measures of treatment satisfaction. The investigators will objectively measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP usage compared to the usual care group. In an exploratory fashion, the investigators will also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime sleepiness, cognitive impairment, and health-related quality of life) and evaluate social cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.
Detailed description
This exploratory study will test the feasibility and initial efficacy of a mobile health smartphone intervention to increase adherence to positive airway pressure (PAP) therapy in newly diagnosed obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics. This app, called SleepWell24, will include PAP adherence behavior change strategies (drawn from the evidence-based Sleep Apnea Self-Management Program), cloud-based linkages to a consumer-based PAP machine and wearable sensor that provides nightly feedback on PAP adherence and sleep and activity metrics, and a component to enhance patient-provider communication. The investigators will embed SleepWell24 within usual patient care at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics for app design/development, patient recruitment, and treatment feasibility/satisfaction. This design will ensure the best opportunity for clinical adoption. The primary aims are:
Aim 1: Determine the feasibility and acceptability of SleepWell24 from patient and provider perspectives.
Aim 2: Determine the extent to which SleepWell24 improves PAP adherence over the first 60 days of use relative to usual care.
As an exploratory aim the investigators will explore the effect of SleepWell24 on treatment outcomes (weight, daytime sleepiness, cognitive performance, health-related quality of life) and putative social cognitive and behavioral mediators of PAP adherence (e.g., self-efficacy, sleep quality, sedentary behavior, physical activity).
The investigators will test the feasibility, acceptability, initial efficacy and outcomes of SleepWell24 compared to usual care during the first 60 days of PAP use among 94 patients newly diagnosed with obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SleepWell24 Application | Experimental | Behavioral: SleepWell24 ApplicationA mobile health smartphone application based on evidence-based health behavior change theory and interventions to promote adherence to positive airway pressure therapy |
| Usual Care Plus Activity Monitor | Other | Other: Usual Care Plus Activity MonitorPer usual clinical care standards within the Center for Sleep Medicine at Mayo Clinic Arizona, all patients will receive instructions/education on positive airway pressure (PAP) use, multiple mask fittings, encouragement to use PAP every night, and staff is available in the event of problems. Control patients will also receive a wearable activity monitor to use during the study. The wearable sensor will be used to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to severe obstructive sleep apnea diagnosed through clinical diagnostic testing and laboratory or home-based sleep study
- current use of appropriate Apple (iOS7 or higher) or Android (2.3 or higher) smartphone device
- Be able to read, write, and understand English
- Prescribed positive airway pressure therapy for obstructive sleep apnea
Key exclusion criteria (12 listed)
- Do not agree to be randomized
- Currently participating in other lifestyle change programs
- Personal, health, cognitive, or psychological conditions that prevent full participation
- Pregnant, lactating, or trying to become pregnant
- Prescribed high-dose benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleepWell24 ApplicationAn evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy | Behavioural | SleepWell24 Application |
| Usual Care Plus Activity MonitorParticipants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app. | Other | Usual Care Plus Activity Monitor |
Primary outcome
Recruitment and Retention
Time frame: Duration of the trial (~60 days)
numbers recruited and retained over the course of the trial
SleepWell24 application usage
Time frame: Duration of the trial (~60 days)
objective metrics of smartphone application usage by intervention group
Treatment acceptability/satisfaction
Time frame: Baseline vs. Day 60 of trial
Intervention acceptability questionnaire for both groups
Positive airway pressure therapy use
Time frame: Duration of the trial (~60 days)
How many hours per night therapy was used throughout the trial
5 secondary outcomes
Body Mass Index
Time frame: Baseline and follow-up visit between days 31 and 60
Daytime Sleepiness
Time frame: Baseline, Day 30, Day 60 of trial
Cognitive functioning
Time frame: Baseline and follow-up visit between days 31 and 60
Global Quality of Life due to physical and mental health via the Patient Reported Outcomes Measurement Information System Global Health Scale
Time frame: Baseline, Day 30, Day 60 of trial
Sleep Apnea-Specific Quality of Life
Time frame: Baseline, Day 30, Day 60 of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 38032115Petrov ME, Epstein DR, Krahn L, Todd M, Park JG, St Louis EK, Morgenthaler TI, Hoffmann CM, Hasanaj K, Hollingshead K, Yu TY, Buman MP. SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial. Behav Sleep Med. 2024 Jul-Aug;22(4):420-432. doi: 10.1080/15402002.2023.2289442. Epub 2023 Nov 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan E Petrov, PhD principal investigator
Arizona State University
Matthew Buman, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepWell24 Application in people with Obstructive Sleep Apnea of Adult, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and Retention (time frame: Duration of the trial (~60 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.