Not Yet RecruitingNot Applicable

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

100 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be at least 21 years of age * Have a referral to the study site from a physician to complete an overnight polysomnogram test for sleep apnea detection or follow-up. * Be willing and able to wear two Wesper Lab patches and an FDA-cleared pulse oximeter in conjunction with a polysomnogram, for a single night. * Be able and voluntarily willing 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 Criteria: * Women who are pregnant, trying to get pregnant or who have a positive urine pregnancy test on the day of the study. * Women who are breast-feeding * History of severe insomnia * Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.

What they're measuring

Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG

Timeframe: 8 Hours

Correlation of the Central Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG

Timeframe: 8 Hours

Trial details

NCT IDNCT07095413

SponsorWesper Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Chelsie E Rohrscheib, Ph.D

8106236374 chelsie@wesper.co