Obstructive Sleep ApneaNCT05112757
Effective Conversion of Individuals at Risk
A study testing Smartphone application use in people with Obstructive Sleep Apnea and Atrial Fibrillation, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Atrial Fibrillation
- What is being tested?
- Smartphone application use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 8 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
- 18 years or older, with sufficient English language skills
- Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<)
- Able to download and handle an app on a smartphone
- Willing and able to give informed consent
Who cannot join
- Diagnosed with OSA and/or AFib
- Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
- Pregnancy/breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis
Read the detailed description
The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.
- Conditions
- Obstructive Sleep Apnea, Atrial Fibrillation
- Being tested
- Smartphone application use
- Keywords
- OSA, AFib
- Medical subject headings
- Sleep Apnea, Obstructive, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application useOther
Use of a smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Smartphone app use Receives: Other: Smartphone application use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective conversion
Number of patients that visited the Primary Care Physician
Measured: 6 months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start24 Feb 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Why it stopped: Very low recruitment success and all recruitment options were exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanford Health
- Responsible party
- Sponsor
- Investigators
- Tim Weysen, MSc, Principal investigator, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112757
- Sponsor's protocol ID
- ICBE-S-000283
- Status last verified
- Dec 2022
- First submitted
- 19 Oct 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Conversion of Individuals at Risk
- ClinicalTrials.gov ID
- NCT05112757
- Acronym / sponsor ID
- ICBE-S-000283
- Conditions
- Obstructive Sleep Apnea, Atrial Fibrillation
- Keywords
- OSA, AFib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low recruitment success and all recruitment options were exhausted
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Sanford Health
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 9 Nov 2021 (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.
This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis
Detailed description
The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Smartphone application useSmartphone app use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
- 18 years or older, with sufficient English language skills
- Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<)
- Able to download and handle an app on a smartphone
- Willing and able to give informed consent
Key exclusion criteria (3 listed)
- Diagnosed with OSA and/or AFib
- Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
- Pregnancy/breast feeding
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 |
|---|---|---|
| Smartphone application useUse of a smartphone application | Other | Intervention |
Primary outcome
Effective conversion
Time frame: 6 months after consent
Number of patients that visited the Primary Care Physician
Results and safety
The study was stopped early (reason given: Very low recruitment success and all recruitment options were exhausted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
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Myofunctional Therapy for Obstructive Sleep Apnea
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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.
Tim Weysen, MSc principal investigator
Philips Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application use in people with Obstructive Sleep Apnea and Atrial Fibrillation, run by Philips Clinical & Medical Affairs Global 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Dec 2022. 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 was stopped early (reason given: Very low recruitment success and all recruitment options were exhausted). Results are not available in the source record.
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?
Effective conversion (time frame: 6 months after consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2022.