TatchSleep as a Tool to Aid in Sleep Apnea Analysis

Wesper Inc

Status: Completed

Conditions: Sleep Disorder; Sleep Apnea

Treatments: Device: TatchSleep

Study type: Interventional

Funder types: Industry

Identifiers

NCT04419714

TCH-103

Details and patient eligibility

About

This is a single center, single-arm, quantitative study evaluating the efficacy of the TatchSleep wireless sensor patches as a tool to aid in sleep apnea analysis as compared to an overnight PSG evaluation.

Full description

This is a multi-center, single-arm, quantitative study evaluating the effectiveness of the TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight PSG evaluation.

Investigators will identify approximately 50 eligible patients who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study.

Patients will undergo their PSG test while simultaneously wearing 2 TatchSleep Pro patches and an FDA-cleared pulse oximeter compatible with and connected to the TatchSleep Pro system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the TatchSleep Pro device and collect the sleep data via the companion smartphone application.

A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events. Following the data collection, sleep data from PSG and TatchSleep Pro will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of TatchSleep Pro compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the TatchSleep Pro data to obtain an estimate of inter-rater reliability.

Enrollment: 53 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be at least 18 years of age
2. Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
3. Be able to read, write, and speak English
4. Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
5. The patient must be able to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.

Exclusion criteria

1. Latex allergy
2. Morbidly obese patients (BMI>39.5)
3. Females who are pregnant, trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
4. Women who are breast-feeding
5. Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

TatchSleep Pro Test Arm

Experimental group

Description:

This is the only arm tested in the study. Individuals within this arm were male and female participants, that were at least 18 years or older. Every participant wore the TatchSleep Pro device while simultaneously undergoing an in-lab PSG.

Treatment:

Device: TatchSleep