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Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations

NCT06218186 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-01-23

No results posted yet for this study

Summary

The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age).

The main question\[s\] it aims to answer are:

* Does Wesper Lab demonstrate agreement with PSG for the calculation of the apnea/hypopnea index (AHI)?
* Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity.

Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter.

Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device.

This is a single center, single-arm, quantitative study

Conditions

  • Sleep Apnea
  • Sleep Apnea Syndromes in Children
  • Sleep Apnea Syndromes

Interventions

DEVICE

Medical Device: Wesper Lab Home Sleep Test

Wesper Lab is a medical device that is used for the diagnosis of sleep apnea. Wesper lab is composed of two flexible biosensors that adhere to the abdomen and thorax with medical grade adhesive. A FDA approved pulse oximeter is worn on a finger.

Sponsors & Collaborators

  • Wesper Inc

    lead INDUSTRY

Principal Investigators

  • German P Digoy, M.D. · Associate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218186 on ClinicalTrials.gov