Status:
NOT_YET_RECRUITING
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
Lead Sponsor:
Wesper Inc
Conditions:
Sleep Apnea
Sleep Apnea Syndromes in Children
Eligibility:
All Genders
2-21 years
Phase:
NA
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 ...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06218186
Start Date
March 1 2024
End Date
April 1 2025
Last Update
January 23 2024
Active Locations (1)
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1
Summit Medical Center
Edmond, Oklahoma, United States, 73013