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Introduction to SleepImage

SleepImage is a clinically proven accurate measure of sleep quality. SleepImage started as a prescription-based medical product with FDA clearance to screen for sleep disorders. The latest guidance on the Low Risk Wellness devices has made it possible for SleepImage to offer two product lines: (1) a model within that guideline to dynamically track sleep quality for the wellness conscious consumer and (2) a prescription-based service through licensed healthcare providers to screen for sleep disorders and track efficacy of therapy. The SleepImage product for the wellness-based consumer does not predict conditions or disease and is not for self-diagnosis.
Both products are based on the same accurate and clinically valid technology, making it possible for licensed healthcare practitioners to look at clinically validated and medically actionable data from a consumer device.

 

 

Validation

SleepImage has been validated in multiple ways: in more than 25 clinical studies, against more than 15,000 Polysomnography Studies (PSG), and by FDA clearance. Further clinical studies are under way and will be published. For a list of published clinical studies, visit www.sleepimage.com/research.
 

 

Two product offerings

The hours asleep are arguably the most important hours of anyone’s life, as it is during sleep that memories get consolidated and muscles rebuilt. Without good quality sleep the immune system weakens and eventually chronic diseases set in. Yet despite the severity of chronic poor sleep, a home sleep test for consumers that is based on clinical science and validated to accurately measure sleep quality has not existed. SleepImage changes that.
 
SleepImage also continues to offer its prescription-based software product that uses the same clinically valid science. In this case, it is medically actionable for sleep disorder screening and therapy tracking and can be used by all licensed healthcare providers as a part of any disease management program.
 
Anyone can sign up for a free user account, and any licensed healthcare provider can sign up for a free clinician account on www.sleepimage.com.

 

A secure and proven system

The secure SleepImage system is provided as a patented cloud-based technology that utilizes a single ECG lead (collecting a person’s electrocardiogram) with a small wearable device that includes an accelerometer and a snore detector to be worn while sleeping in the comfort of home. The system uses heart rate variability, breathing patterns, snoring, body position, and movement to provide measurements of sleep quality, presented as stable sleep (a.k.a. deep sleep, delta waves, or slow wave sleep) – the restorative and rejuvenating part of sleep, both for the brain and the body.Stable sleep is a proven and objective measure of sleep quality.
 

 

The wellness product

The product consists of the following components:

  • The SleepImage data recorder kit
    • Priced at $249
    • The device can be shared by users and can be purchased by either a user or healthcare provider.
  • The software application
    • Anyone can set up a user account, free of charge
    • $99 for an annual membership and unlimited use
    • $19 for each additional user (up to 3 additional users on each membership account).

 

The prescription product

  • The prescription product is a software application for licensed healthcare providers who have registered for a clinician account and have patients under their care who have registered for a user account on www.sleepimage.com.
    • Clinician accounts are free of charge.
    • Clinicians can purchase clinical reports for their patients who do not have annual memberships, for as little as $19 for one report.
    • Upgrade to an annual membership and unlimited use (for wellness members) for $50, or $149 for users without wellness membership.
    • The prescription product is limited to users with a prescription.
  • Users can invite their healthcare provider, or healthcare providers can invite their patients through a secure portal on www.sleepimage.com to access users' sleep data. Prescription has been established when the healthcare provider has accepted an invitation from the user (or sent an invitation to a user who has accepted). 
  • Cloud-based data sharing makes it easy to access and interpret sleep data. Easy links between patient and clinicians makes the data easily sharable.

 

Insurance reimbursement

SleepImage provides clinical information to be used by a provider for clinical assessment. The only cost for the healthcare provider (when patients have an annual membership) is the consult time to read and interpret the data. Specific insurance reimbursement for SleepImage is not available at this time.
 

 

Account types

A wellness conscious consumer registers for a free user account on www.sleepimage.com
A licensed healthcare provider registers for a free clinician account on www.sleepimage.com
 

 

The user experience

Sign in at www.sleepimage.com, click the link on the website, and follow the prompts to set up a free account – either as a user or as a clinician. (Clinician accounts are only available to licensed healthcare providers.)

Devices can be purchased on www.sleepimage.com after signing in to either of the secure account types.

Annual membership (both wellness membership and patient membership) can be purchased on www.sleepimage.com after signing in to the secure user account.

Clinical reports can be purchased on the website after signing in to the secure clinician account.

Patients can share their sleep studies directly with as many healthcare providers as they choose through the portal. A patient might want to share his/her sleep data with his/her primary care physician, sleep specialist, cardiologist, psychiatrist, psychologist, dentist, chiropractor, or any other licensed healthcare provider who is treating the patient for poor sleep.

Two types of annual membership:
Annual wellness membership for unlimited use – available to anyone

Annual prescription membership for unlimited use – available for patients under the care of their licensed healthcare provider(s), who can be invited directly from the secure www.sleepimage.com to access their data for sleep disorder screening or therapy tracking.  Licensed healthcare providers who have a clinician account on www.sleepimage.com can also invite their patients. Both the clinician and the patient must sign up for a free account on www.sleepimage.com to be able to invite the other. 


 

 

Data interpretation

SleepImage makes it easy for healthcare providers and their patients to share and review the patients’ sleep data. Healthcare providers who are new to SleepImage typically need about 30 minutes of training to effectively use the SleepImage System. There is a clinician guide to SleepImage available on www.sleepimage.com
 

 

The business model for SleepImage

A dual approach to market:

Direct to consumer – consumer owns the device and buys an annual membership to track sleep quality. The consumer can invite his/her healthcare provider to access their sleep data (at which time the consumer becomes the patient of the healthcare provider) to screen for sleep disorders or to track therapy efficacy as part of any disease management.

Clinician to patient – the healthcare practice owns the device and lends it to the patient. The clinician either buys clinical SleepImage reports for patients who do not have an annual membership, or accesses data for patients who have an annual membership.
 

 

The core value offered by the SleepImage

SleepImage is based on a clinically validated and FDA-cleared algorithm to measure sleep quality. It objectively and accurately looks at the autonomous nervous system through the ECG and respiration. The benefit is the ability to provide clinical data that is medically actionable from a simple home-based system.
 

 

About the company

SleepImage is exploring opportunities to collaborate and build partnerships around this technology to address different markets throughout the world.
 

 

For specific sleep-related questions for wellness-conscious individuals

1. Questions about SleepImage in the clinic - Introduction to SleepImage
2. Questions about science behind SleepImage - Published Clinical Papers
3. Questions about how to use SleepImage in the clinic - Clinician's Guide to SleepImage