Clinical Trial

Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea

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Record status
This record was last updated July 31, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07095413
Lead Sponsor Wesper Inc
Conditions Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea, Central
Enrollment 100 participants
Start Date 2025-09-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-31