TatchSleep as a Tool to Aid in Sleep Apnea Analysis

NCT04419714 | Completed Results FDA Device

• 1 other identifier: TCH-103
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 hours

Secondary Outcomes (2)

• Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography

  12 hours

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

  12 hours

Study Arms (1)

TatchSleep Pro Test Arm

EXPERIMENTAL

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.

Device: TatchSleep

Interventions

TatchSleep DEVICE

Wearable measurement device

TatchSleep Pro Test Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wesper Inc: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was conducted at a single site with a relatively small sample size (n = 45), which may limit generalizability

Results Point of Contact

• Title: Amir Reuvent
• Organization: Wesper/Tatch

amir@wesper.co

5754482824

Study Officials

• Imran M Ahmed, MD

  ontefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Suzanne Pearson, RPSGT, RST

  The Valley Hospital Center for Sleep Medicine

  PRINCIPAL INVESTIGATOR

• Matthew L Uhles, RPSGT, RST

  Clayton Sleep Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: June 10, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)