Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
NCT07095413 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-07-31
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.
Conditions
- Sleep Apnea
- Sleep Apnea, Obstructive
- Sleep Apnea, Central
Interventions
- DIAGNOSTIC_TEST
-
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.
Sponsors & Collaborators
-
Wesper Inc
lead INDUSTRY
Principal Investigators
-
Chelsie E Rohrscheib, Ph.D · Attend a workshop
-
Ruchir P Patel, M.D. · The Insomnia and Sleep Institute of Arizona
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2025-12-01
- Completion
- 2026-02-01
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