Validation of Sleep Apnea Screening Device Phase II
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/16/2018 |
| Start Date: | November 14, 2017 |
| End Date: | March 31, 2019 |
Wireless Sensor Patch for Educing Barriers to In-home Sleep Apnea Screening, Phase II
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. 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. Over the past year,
this investigative team has engineered a small screening device (Zerify®) for OSA and
obtained preliminary evidence of its efficacy in a clinical population under a
NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a
small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,
transfer these data to a computer, and detect non-clinical simulated apnea events with a
specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary
psychometric performance data of the screening device in a clinical sample of 52 patients
(13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard
polysomnography. Phase II proposal aims to optimize the engineered hardware and associated
OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,
and compare the efficacy of this screening device to the most commonly utilized sleep apnea
screener, the home sleep apnea test (HSAT).
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. Over the past year,
this investigative team has engineered a small screening device (Zerify®) for OSA and
obtained preliminary evidence of its efficacy in a clinical population under a
NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a
small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,
transfer these data to a computer, and detect non-clinical simulated apnea events with a
specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary
psychometric performance data of the screening device in a clinical sample of 52 patients
(13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard
polysomnography. Phase II proposal aims to optimize the engineered hardware and associated
OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,
and compare the efficacy of this screening device to the most commonly utilized sleep apnea
screener, the home sleep apnea test (HSAT).
An alternative to polysomnography (PSG), which is done overnight in a lab, is home sleep
apnea testing (HSAT). Also known as out-of-center testing, HSAT has emerged as a more
convenient and increasingly widely used method to screen for sleep apnea. HSAT records fewer
signals for assessment, is less cumbersome than traditional PSG, and allows patients to spend
the night at home, eliminating the need for technical staff to be present during testing.
HSAT is considerably less expensive than PSG to perform. Despite its advantages, there are
concerns about false-negatives and underestimation of disease severity with HSAT. There is
clearly a need to improve the accuracy of less costly screening tools for OSA. Zansors®
wireless microsensor is a novel device to screen for sleep apnea, which measures breathing
patterns and movement, and which will collect data and communicate with a smartphone via
Bluetooth. In this study, investigators are comparing the Zansors microsensor to HSAT and PSG
to assess its accuracy. Patients will be asked to wear the device during the clinical HSAT
ordered by their doctor, and again at an in-laboratory sleep study. When patients are being
trained to use the HSAT equipment, research staff will also show them how to put the Zansors®
device on. They will then wear it at home on the night of their HSAT. At a later date, when
they come for the in-laboratory sleep study, the device will again be worn overnight while
they are being assessed by the full PSG equipment. Together in this study, all these device
recordings will help to detect any sleep apnea and researchers will compare the results of
the Zansors ® microsensor with HSAT and PSG equipment. If the Zansors ® device is confirmed
to detect sleep hypopneas and apneas accurately, it can be used easily and inexpensively by
people at home to screen for obstructive sleep apnea.
apnea testing (HSAT). Also known as out-of-center testing, HSAT has emerged as a more
convenient and increasingly widely used method to screen for sleep apnea. HSAT records fewer
signals for assessment, is less cumbersome than traditional PSG, and allows patients to spend
the night at home, eliminating the need for technical staff to be present during testing.
HSAT is considerably less expensive than PSG to perform. Despite its advantages, there are
concerns about false-negatives and underestimation of disease severity with HSAT. There is
clearly a need to improve the accuracy of less costly screening tools for OSA. Zansors®
wireless microsensor is a novel device to screen for sleep apnea, which measures breathing
patterns and movement, and which will collect data and communicate with a smartphone via
Bluetooth. In this study, investigators are comparing the Zansors microsensor to HSAT and PSG
to assess its accuracy. Patients will be asked to wear the device during the clinical HSAT
ordered by their doctor, and again at an in-laboratory sleep study. When patients are being
trained to use the HSAT equipment, research staff will also show them how to put the Zansors®
device on. They will then wear it at home on the night of their HSAT. At a later date, when
they come for the in-laboratory sleep study, the device will again be worn overnight while
they are being assessed by the full PSG equipment. Together in this study, all these device
recordings will help to detect any sleep apnea and researchers will compare the results of
the Zansors ® microsensor with HSAT and PSG equipment. If the Zansors ® device is confirmed
to detect sleep hypopneas and apneas accurately, it can be used easily and inexpensively by
people at home to screen for obstructive sleep apnea.
Inclusion Criteria:
- Must be over 18 and referred by medical staff for an assessment for suspected sleep
apnea using either a home sleep apnea testing device or in-lab PSG equipment
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
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