Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea screening device
Brief summary
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.
Detailed description
Obstructive Sleep Apnea (OSA) results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. The gold-standard method for diagnosing OSA is in-laboratory polysomnography; however, this procedure is generally available only to patients with health insurance due to its high cost. As a result, communities at particularly high risk for OSA are less likely to have this serious sleep disorder appropriately diagnosed and treated. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Zansors® has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies: 1. an adjustable microphone; 2. a 3-axis accelerometer; 3. embedded algorithms to measure sleep events; and 4. acrylic adhesive. The product will be designed as an FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The features of this product include that it is home-based; easy to use; non-invasive; wireless; disposable; low cost ($20-50); and presents easily understandable test results. However, such a device must first be validated against gold-standard polysomnography. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.
Interventions
DEVICEZansors® sleep screening device
Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Sponsors
Zansors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be over 18 and referred by medical staff for an overnight assessment for suspected sleep apnea
Exclusion criteria
* Pregnancy * Heart disease including congestive heart failure or a pacemaker * Breathing disorder (emphysema or chronic obstructive breathing disorder) * Neurological disorder such as Parkinson's Disease * Restless leg syndrome or Periodic limb movement * Allergies to metal * Pre-existing skin conditions where sensor would be attached
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 8 hours | Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 8 hours | Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals |
| Positive Predictive Value (PPV) | 8 hours | PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals |
| Negative Predictive Value (NPV) | 8 hours | NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zansors® Sleep Screening Device Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Zansors® Sleep Screening Device |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Specificity
Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zansors® Sleep Screening Device | Specificity | 71.4 percentage of true negatives |
Secondary
Negative Predictive Value (NPV)
NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zansors® Sleep Screening Device | Negative Predictive Value (NPV) | 0.77 negative predictive value |
Secondary
Positive Predictive Value (PPV)
PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zansors® Sleep Screening Device | Positive Predictive Value (PPV) | 0.692 positive predictive value |
Secondary
Sensitivity
Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zansors® Sleep Screening Device | Sensitivity | 75 percentage of true positives |