Wesper Lab Home Test for Sleep Apnea in Children

Recruiting in Palo Alto (17 mi)

Overseen byGerman P Digoy, M.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tatch Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

German P Digoy, M.D.

Principal Investigator

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

Eligibility Criteria

This trial is for children and young adults aged 2 to 21 who are already scheduled for a standard sleep study (PSG) to check for sleep apnea. Participants will use the Wesper Lab home test at the same time as their regular PSG.

Inclusion Criteria

My doctor referred me for an overnight sleep test to check for sleep apnea.

I can sign the consent form myself, or if under 18, my guardian can.

I am willing to wear sleep study devices for one night.

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Exclusion Criteria

I am under 2 years old.

I am over 21 years old.

Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study

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Treatment Details

Interventions

Wesper Lab (Medical Device)

Trial OverviewThe study tests how well the Wesper Lab, a wireless home sleep test device, measures sleep apnea compared to traditional overnight polysomnography. It checks if both methods agree on the severity of sleep apnea in participants.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Medical Device: Wesper Lab (Single Arm)Experimental Treatment1 Intervention

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.