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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Wesper Lab Home Sleep Apnea Test
Diagnostic testSubjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Medical Device: Wesper Lab Home Sleep Apnea TestOther 1 intervention
Trial outcomes
Primary outcomes
1
Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG
The primary outcome measure is to assess the correlation between the apnea-hypopnea index (AHI) and obtained from the Wesper Lab wireless sensors and those derived from the polysomnography (PSG) recordings.
Time frame
8 Hours2
Correlation of the Central Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG
The primary outcome measure is to assess the correlation between the apnea-hypopnea index (CAHI) and obtained from the Wesper Lab wireless sensors and those derived from the polysomnography (PSG) recordings.
Time frame
8 HoursSecondary outcomes
1
Inter-Rater Reliability
Assess the consistency of signal scoring among different readers using the Wesper Lab device.
Time frame
8 Hours2
Agreement in Apnea Classification
Evaluate the concordance between the Wesper Lab sensors and PSG in classifying the severity of apnea (mild, moderate, severe).
Time frame
8 Hours3
Classification of Apnea Type
To determine the agreement between the Wesper Lab sensors and PSG in identifying the type of apnea (Obstructive Sleep Apnea (OSA) vs. Central Sleep Apnea (CSA)).
Time frame
8 hours4
Agreement in Respiratory Event Detection by Optical Sensors - AHI
To determine the agreement between the Wesper Lab optical sensors and PSG in determining the apnea/hypopnea index (AHI).
Time frame
8 HoursLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: