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

January 11, 2024 updated by: Tatch Inc.

A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population.

Investigators will identify approximately 150 eligible pediatric patients, 50 subjects per subgroup, who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. Subgroups include pediatric patients in the following age ranges: subgroup 1: 2-5 years old, subgroup 2: 6-11 years old, subgroup 3: 12-21 years old.

After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential (12 years or older) 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 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab 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 Wesper Lab 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 Wesper Lab will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the Wesper Lab data to obtain an estimate of inter-rater reliability.

Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal. The performance goal is based on a meta-analysis of FDA-cleared similar devices. Fisher's transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0.025. The upper and lower 95% Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices. Deming regression will also be presented. The inter-rater reliability of Wesper Lab AHIs will be calculated.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chelsie E Rohrscheib, Ph.D
  • Phone Number: 18106236374
  • Email: chelsie@wesper.co

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Summit Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be 2 to 21 years of age.
  • Have a referral to the study site from a physician to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
  • Be willing and able to wear two Wesper Lab patches and an FDA-cleared pulse oximeter in conjunction with a polysomnogram, for a single night.
  • If 18 years or older, be able to willingly sign a written informed consent form prior to the initiation of any study procedure. If younger than 18 years of age, have a parent or legal guardian voluntarily willing 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:

  • Individuals younger than 2 years of age.
  • Individuals older than 21 years of age
  • Females 12 years or older who have a positive urine pregnancy test on the day of the study.
  • Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Device: Wesper Lab (Single Arm)
Participants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).
Time Frame: 8 hours

The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.

The primary outcome measure of this study is to determine there is sufficient agreement between the AHI measured by Wesper Lab with the AHI measured by PSG.
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.
Time Frame: 8 hours

The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.

Sleep apnea severity is calculated with AHI as determined by the American Academy of Sleep Medicine.

Normal: AHI = 0 - 4.99 Mild: AHI = 5 - 14.99 Moderate: AHI = 15 - 29.99 Severe: AHI = >30

The secondary outcome measure is to determine there is sufficient agreement between the sleep apnea severity measured by Wesper Lab with the sleep apnea severity measured by PSG.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatch Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSP-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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