Sleep ApneaNCT07095413
Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
A study testing Wesper Lab Home Sleep Apnea Test in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Wesper Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea, Central
- What is being tested?
- Wesper Lab Home Sleep Apnea Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amir Reuveny, Ph.D contact
About this study
Official title: Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea Diagnosis in Adult Populations
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:
- 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?
- Is Wesper Lab accurate in a wide range of body types and skin types?
Read more
Participants will:
- Provide informed consent and complete a brief medical history.
- Undergo an overnight polysomnography sleep study while wearing two Wesper Lab patches and a compatible pulse oximeter.
- Have a follow-up communication within 5 days post-study to assess any adverse events.
Read the detailed description
This study aims to validate the Wesper Lab wireless sensors as a reliable alternative to traditional PSG for diagnosing sleep apnea, potentially providing a more convenient method for patients while maintaining diagnostic accuracy. The structured approach to data collection, monitoring, and follow-up underscores a thorough methodology to assess both effectiveness and safety. The study is a single-center, single-arm clinical trial designed to evaluate the effectiveness of the Wesper Lab wireless sensors for aiding in the diagnosis of sleep apnea, specifically comparing its performance to overnight polysomnography (PSG).
The primary aim is to determine how well the Wesper Lab wireless sensors correlate with traditional PSG results in measuring obstructive sleep apnea (OSA) and central sleep apnea (CSA) through key metrics, specifically the apnea-hypopnea index (AHI) and central apnea/hypopnea index (CAHI).
Approximately 100 eligible adult patients (≥21 years) who have been referred by a physician for an overnight PSG test to evaluate sleep apnea.
Patients will undergo PSG testing while simultaneously wearing two Wesper Lab sensors and a compatible pulse oximeter for one night at the clinic. Sleep technicians will monitor and set up the devices, and data will be collected via a smartphone app linked to the Wesper Lab system. The PSG will record brain activity, blood oxygen levels, heart rate, breathing patterns, and movements. Data will be collected during the sleep period, and post-study, the signals will be analyzed by qualified readers who are blinded to the device used for data collection.
To demonstrate that the correlation between the AHI/CAHI from the Wesper Lab and PSG exceeds a predefined performance goal (PG) using Pearson correlation. To establish that the 95% limits of agreement between AHI/CAI from the two devices fall within acceptable upper and lower limits. Evaluate inter-rater reliability of AHI/CAHI readings. Assess agreement in apnea classification (mild, moderate, severe) between the two methods.
Analyze differences based on sleep position (supine vs. non-supine).
The primary safety endpoints include tracking adverse events (AEs) and serious adverse events (SAEs) related to the use of the Wesper Lab device throughout the study.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea, Central
- Being tested
- Wesper Lab Home Sleep Apnea Test
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wesper Lab Home Sleep Apnea TestDiagnostic test
Subjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter.
| Study group | Role | What they receive |
|---|---|---|
| Medical Device: Wesper Lab Home Sleep Apnea Test | Other | This arm consists of participants who will undergo an overnight polysomnography (PSG) evaluation while simultaneously wearing the Wesper Lab home sleep apnea tests. Receives: Diagnostic Test: Wesper Lab Home Sleep Apnea Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Hours
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.
Measured: 8 Hours
Secondary outcomes (6)
Inter-Rater Reliability
Assess the consistency of signal scoring among different readers using the Wesper Lab device.
Measured: 8 Hours
Agreement in Apnea Classification
Evaluate the concordance between the Wesper Lab sensors and PSG in classifying the severity of apnea (mild, moderate, severe).
Measured: 8 Hours
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)).
Measured: 8 hours
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).
Measured: 8 Hours
Agreement in Total Sleep Time by Optical Sensors
To determine the agreement between the Wesper Lab optical sensors and PSG for estimating total sleep time.
Measured: 8 Hours
Agreement in Respiratory Event Detection by Optical Sensors - CAHI
To determine the agreement between the Wesper Lab optical sensors and PSG in determining the central apnea/hypopnea index (CAHI).
Measured: 8 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will wear the Wesper Lab sensors while undergoing the Polysomnography (PSG) test. The study focuses on evaluating the performance of the Wesper Lab sensors in the context of standard PSG without a separate control or comparison group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wesper Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chelsie E Rohrscheib, Ph.D, Study director, Attend a workshopRuchir P Patel, M.D., Principal investigator, The Insomnia and Sleep Institute of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095413
- Sponsor's protocol ID
- WSP-222
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available to share with researchers no associated with Wesper Inc.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea Diagnosis in Adult Populations
- ClinicalTrials.gov ID
- NCT07095413
- Acronym / sponsor ID
- WSP-222
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wesper IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Is Wesper Lab accurate in a wide range of body types and skin types?
Participants will:
- Provide informed consent and complete a brief medical history.
- Undergo an overnight polysomnography sleep study while wearing two Wesper Lab patches and a compatible pulse oximeter.
- Have a follow-up communication within 5 days post-study to assess any adverse events.
Detailed description
This study aims to validate the Wesper Lab wireless sensors as a reliable alternative to traditional PSG for diagnosing sleep apnea, potentially providing a more convenient method for patients while maintaining diagnostic accuracy. The structured approach to data collection, monitoring, and follow-up underscores a thorough methodology to assess both effectiveness and safety. The study is a single-center, single-arm clinical trial designed to evaluate the effectiveness of the Wesper Lab wireless sensors for aiding in the diagnosis of sleep apnea, specifically comparing its performance to overnight polysomnography (PSG).
The primary aim is to determine how well the Wesper Lab wireless sensors correlate with traditional PSG results in measuring obstructive sleep apnea (OSA) and central sleep apnea (CSA) through key metrics, specifically the apnea-hypopnea index (AHI) and central apnea/hypopnea index (CAHI).
Approximately 100 eligible adult patients (≥21 years) who have been referred by a physician for an overnight PSG test to evaluate sleep apnea.
Patients will undergo PSG testing while simultaneously wearing two Wesper Lab sensors and a compatible pulse oximeter for one night at the clinic. Sleep technicians will monitor and set up the devices, and data will be collected via a smartphone app linked to the Wesper Lab system. The PSG will record brain activity, blood oxygen levels, heart rate, breathing patterns, and movements. Data will be collected during the sleep period, and post-study, the signals will be analyzed by qualified readers who are blinded to the device used for data collection.
To demonstrate that the correlation between the AHI/CAHI from the Wesper Lab and PSG exceeds a predefined performance goal (PG) using Pearson correlation. To establish that the 95% limits of agreement between AHI/CAI from the two devices fall within acceptable upper and lower limits. Evaluate inter-rater reliability of AHI/CAHI readings. Assess agreement in apnea classification (mild, moderate, severe) between the two methods.
Analyze differences based on sleep position (supine vs. non-supine).
The primary safety endpoints include tracking adverse events (AEs) and serious adverse events (SAEs) related to the use of the Wesper Lab device throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will wear the Wesper Lab sensors while undergoing the Polysomnography (PSG) test. The study focuses on evaluating the performance of the Wesper Lab sensors in the context of standard PSG without a separate control or comparison group.
| Arm | Type | Receives |
|---|---|---|
| Medical Device: Wesper Lab Home Sleep Apnea Test | Other | Diagnostic Test: Wesper Lab Home Sleep Apnea TestThis arm consists of participants who will undergo an overnight polysomnography (PSG) evaluation while simultaneously wearing the Wesper Lab home sleep apnea tests. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wesper Lab Home Sleep Apnea TestSubjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter. | Diagnostic test | Medical Device: Wesper Lab Home Sleep Apnea Test |
Primary outcome
Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG
Time frame: 8 Hours
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.
Correlation of the Central Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG
Time frame: 8 Hours
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.
6 secondary outcomes
Inter-Rater Reliability
Time frame: 8 Hours
Agreement in Apnea Classification
Time frame: 8 Hours
Classification of Apnea Type
Time frame: 8 hours
Agreement in Respiratory Event Detection by Optical Sensors - AHI
Time frame: 8 Hours
Agreement in Total Sleep Time by Optical Sensors
Time frame: 8 Hours
Agreement in Respiratory Event Detection by Optical Sensors - CAHI
Time frame: 8 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. No IPD will be available to share with researchers no associated with Wesper Inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Reuveny, Ph.D contact
Chelsie E Rohrscheib, Ph.D study director
Attend a workshop
Ruchir P Patel, M.D. principal investigator
The Insomnia and Sleep Institute of Arizona
Questions about this trial
What is this clinical trial studying?
A study testing Wesper Lab Home Sleep Apnea Test in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Wesper Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsie E Rohrscheib, Ph.D (8106236374, chelsie@wesper.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG (time frame: 8 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.