N/A Completed N=53 Diagnostic

TatchSleep as a Tool to Aid in Sleep Apnea Analysis

sleep apnea · Sleep Disorders, Intrinsic

Source: ClinicalTrials.gov NCT04419714 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcomePrimary: Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI) — 0.95 correlation coefficient (r)

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI)	0.95	—
SECONDARY Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography	89	—
SECONDARY Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa	0.82	—

Eligibility Criteria

Inclusion Criteria

Be at least 18 years of age
Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
Be able to read, write, and speak English
Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04419714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.