Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWesper Inc
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Wesper Lab Home Sleep Apnea Test
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov