Skip to main content
OpenTrials
Completed

NCT Number: NCT04419714

TatchSleep as a Tool to Aid in Sleep Apnea Analysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TatchSleep

Device

Wearable measurement device

Primary outcomes

  1. Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI)

    Time frame: 12 hours

    The correlation between AHI (3% desaturation criterion) measured by the TatchSleep Pro device and in-lab PSG will be assessed. Agreement between the two modalities will be analyzed using Bland-Altman analysis, and Pearson correlation coefficients will be calculated for AHI and ODI (3%). This outcome evaluates the concordance between TatchSleep Pro and PSG for key respiratory indices.

Secondary outcomes

  1. Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography

    Time frame: 12 hours

    Agreement in AHI severity classification (Normal, Mild, Moderate, Severe) between TatchSleep Pro and in-lab PSG was assessed using blinded scoring. Severity assignments from both devices were compared using percent agreement.

  2. Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa

    Time frame: 12 hours

    Agreement in AHI severity classification (Normal, Mild, Moderate, Severe) between TatchSleep Pro and in-lab PSG was assessed using blinded scorers. The level of agreement was quantified using the weighted Cohen's kappa coefficient.

Sponsors and collaborators

Lead sponsor

Wesper Inc

Industry

Registry information

Official study title

A Single Center, Single Arm, Quantitative Study Assessing Performance of TatchSleep as a Tool to Aid in Sleep Apnea Analysis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.