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

Launched by WESPER INC · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new home sleep test called Wesper Lab, which is designed to help diagnose sleep apnea in children and young adults aged 2 to 21 years. Sleep apnea is a condition where breathing stops and starts during sleep, which can affect a person's health. The researchers want to see how well the Wesper Lab device works compared to a traditional overnight sleep study called polysomnography (PSG). Both tests will be done at the same time, allowing the researchers to compare the results and determine if Wesper Lab is an accurate tool for diagnosing sleep apnea.

To participate in this study, children and young adults must be between 2 and 21 years old and have a doctor's referral for a sleep study. They will need to wear two small patches from the Wesper Lab device and an FDA-approved pulse oximeter (a small device that measures blood oxygen levels) while they undergo the PSG for one night. If the participant is 18 or older, they can sign the consent form themselves; if they are younger, a parent or guardian must sign it for them. The study is not yet recruiting participants, but it aims to provide valuable information on how this new home test can help identify sleep apnea in children and young adults.

Gender

ALL

Eligibility criteria

• 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.