BTA | Tatch – HITLAB

Digital Health Technology for Sleep Apnea Diagnosis

Findings on the tatch sleep patch

At least 25 million Americans have sleep apnea, and 80% are undiagnosed

Sleep tests are crucial to diagnose disorders and are difficult to conduct

An opportunity exists for an easier and less invasive at-home test that can potentially decrease the rate of patients with undiagnosed sleep apnea

Tatch is a wireless adhesive patch for the detection of sleep disorders.

Tatch is a flexible, thin, and wireless adhesive patch that is designed to detect sleep disorders in patients. It is smaller and less invasive compared to currently available sleep tests.

It measures respiratory effect, body position, flow, movement, oxygen level, snoring, heart rate, and uses plethysmograph to measure blood flow fluctuation and pulse oximetry.

Data is transmitted via Bluetooth throughout the night to a mobile app. Data from the patch is transmitted via Bluetooth throughout the night to a companion mobile application, which stores the data for clinicians.

Adhesive patch

That is thin and flexible

measurements

Include respiratory effect, oxygen level, and heart rate

Less invasive

Than currently-available sleep tests

companion app

Stores the data for clinicians

CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.

Between March and May 2018, HITLAB conducted a pilot study of the Tatch technology to assess feasibility, comfort, and preliminary effectiveness.

HITLAB conducted a research study wherein patients who were already scheduled for an overnight polysomnogram (PSG) evaluation for sleep apnea (Arm 1) and patients who had undergone a home sleep test for sleep apnea in the past year (Arm 2) were instructed to wear two patches throughout their sleep for one night.

"With this [device], you can just put a shirt over it and no one will see. I didn’t even tell my roommate, she didn’t notice, she just thought it was my iPhone charging."

—tatch Study Participant

key findings

Patients perceive polysomnograms to be a poor indicator of their natural sleep

100 percent of participants felt that Tatch was more comfortable than a standard HST and viewed Tatch as less invasive, less restrictive and easy to use

All participants reported being interested in seeing their sleep data from the study

While early stage, there is indication of correlation between the Tatch and polysomnography devices

Patch design and placement needs to take diverse body types into account

Site staff reported that Tatch was much easier to set up than full polysomnography equipment

Financially, this would be cheaper for a study. I had a $650 bill from a sleep test. This is far more reasonable as an aid for diagnostics.

—tatch Study Participant

recent developments

updated january 2020

Tatch is currently running two clinical studies in hospitals and has three more pilot studies

FDA submission of the patch is upcoming

Tatch has doubled their funding and tripled the size of their team since the time of the hitlab study

"The other [sleep test] felt like a medical device, especially with the nostril medical tubes. I wasn’t a fan of that at all. with tatch, i can sleep normally, with my arm on my chest and not disturb it."

—tatch Study Participant

HITLAB Breakthrough Alliance was created to accelerate a greater number of digital health innovations through the generation of exclusive, evidence-based research and insights. This new digital health consortium is a subscription-based service with a mission to improve health outcomes and care delivery from verifying emerging technologies and research—driven by the perspectives and strategies of its members.

Making a difference in healthcare together, by accelerating evidence-based digital solutions.