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

Status unconfirmed · Not applicable

Conditions studied: Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes

In brief

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

Key facts

Study ID

NCT06218186

Run by

Wesper Inc

People needed

150

Starts

2024-03-01

Expected to finish

2025-04-01

Last updated by the study team

2024-01-23

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Summit Medical Center — Edmond, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.