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

NCT06218186 | Unknown FDA Device

• 1 other identifier: WSP-111
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep Apnea; Pediatric Sleep Apnea; Home Sleep Test; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).

  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 Outcomes (1)

• Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.

  8 hours

Study Arms (1)

Medical Device: Wesper Lab (Single Arm)

EXPERIMENTAL

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

Interventions

Medical Device: Wesper Lab Home Sleep Test DEVICE

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.

Medical Device: Wesper Lab (Single Arm)

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wesper Inc: lead

Study Sites (1)

Summit Medical Center

Edmond, Oklahoma, 73013, United States

Location

Related Publications (2)

• Raphelson JR, Ahmed IM, Ancoli-Israel S, Ojile J, Pearson S, Bennett N, Uhles ML, Rohrscheib C, Malhotra A. Evaluation of a novel device to assess obstructive sleep apnea and body position. J Clin Sleep Med. 2023 Sep 1;19(9):1643-1649. doi: 10.5664/jcsm.10644.

  PMID: 37140998 RESULT

• Zandieh S, Kirschenbaum MA, Greenberg H, Ancoli-Israel S. Keep it simple: A novel technique for measuring airflow using a wireless patch. Sleep Health. 2023 Feb;9(1):100-107. doi: 10.1016/j.sleh.2022.10.005. Epub 2022 Dec 5.

  PMID: 36473786 RESULT

Related Links

• Investigational Device

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• German P Digoy, M.D.

  Associate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsie E Rohrscheib, Ph.D

CONTACT

18106236374; chelsie@wesper.co

Amir Reuveny, Ph.D

CONTACT

amir@wesper.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All studies will be presented on the same viewing and scoring platform. The sleep study readers will be blinded to patient identification and the data collection device for each study.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Medical device, single arm. All subjects will be provided with the same medical device (Wesper Lab), a home sleep test.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)