Status:
COMPLETED
TatchSleep as a Tool to Aid in Sleep Apnea Analysis
Lead Sponsor:
Wesper Inc
Conditions:
Sleep Apnea
Sleep Disorder
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
This is a single center, single-arm, quantitative study evaluating the efficacy of the TatchSleep wireless sensor patches as a tool to aid in sleep apnea analysis as compared to an overnight PSG evalu...
Detailed Description
This is a multi-center, single-arm, quantitative study evaluating the effectiveness of the TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight PSG eva...
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
- Be able to read, write, and speak English
- Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
- The patient must be able 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
- Latex allergy
- Morbidly obese patients (BMI\>39.5)
- Females who are pregnant, trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
- Women who are breast-feeding
- 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 :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04419714
Start Date
June 10 2021
End Date
November 4 2021
Last Update
August 20 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467