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Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
Sponsor: Wesper Inc
Summary
The goal of this clinical trial is to evaluate the effectiveness of the Wesper Lab home sleep apnea test as a tool to aid in the diagnosis of sleep apnea in adult patients (age ≥21 years) who are recommended for an overnight polysomnography (PSG) evaluation. The main questions it aims to answer are: 1. Is Wesper Lab home sleep apnea test as accurate as an in-laboratory sleep study (polysomnography) for the diagnosis of obstructive and central sleep apnea? 2. Is Wesper Lab accurate in a wide range of body types and skin types? Participants will: 1. Provide informed consent and complete a brief medical history. 2. Undergo an overnight polysomnography sleep study while wearing two Wesper Lab patches and a compatible pulse oximeter. 3. Have a follow-up communication within 5 days post-study to assess any adverse events.
Official title: Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea Diagnosis in Adult Populations
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-09-01
Completion Date
2026-02-01
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
Wesper Lab Home Sleep Apnea Test
Subjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter.