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

Sponsor
Wesper Inc
Study ID
NCT07095413
Status
Not Yet Recruiting

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Conditions

  • Sleep Apnea
  • Sleep Apnea, Central
  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wesper Lab Home Sleep Apnea Test — DIAGNOSTIC_TEST
    Subjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter.

Study Details

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.

Key Dates

First listed
Jul 31, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Feb 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Medical Device: Wesper Lab Home Sleep Apnea Test
    This arm consists of participants who will undergo an overnight polysomnography (PSG) evaluation while simultaneously wearing the Wesper Lab home sleep apnea tests.

Primary Outcome Measure

Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG [ Time Frame: 8 Hours ]

Central Contacts

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