Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea (NCT07095413) | Clinical Trial Compass
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 range
21 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG
Timeframe: 8 Hours
2
Correlation of the Central Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG