Sleep ApneaNCT06218186
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
A study testing Medical Device: Wesper Lab Home Sleep Test in people with Sleep Apnea and Sleep Apnea Syndromes in Children, run by Wesper Inc at 1 site in United States.
Trial summary
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age). Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- What is being tested?
- Medical Device: Wesper Lab Home Sleep Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be 2 to 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.
- If 18 years or older, be able to willingly sign a written informed consent form prior to the initiation of any study procedure. If younger than 18 years of age, have a parent or legal guardian 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
- Individuals younger than 2 years of age.
- Individuals older than 21 years of age
- Females 12 years or older who have a positive urine pregnancy test on the day of the study.
- Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.
Trial locations and contacts
1 site in 1 country.
Amir Reuveny, Ph.D contact
United States1 site
Summit Medical Center
Edmond, Oklahoma, 73013
Lindsay Beaty, 405-590-6057, lbeaty@rxokc.com
About this study
Official title: A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age).
The main question[s] it aims to answer are:
Read more
- Does Wesper Lab demonstrate agreement with PSG for the calculation of the apnea/hypopnea index (AHI)?
- Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity.
Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter.
Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device.
This is a single center, single-arm, quantitative study
Read the detailed description
This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population.
Investigators will identify approximately 150 eligible pediatric patients, 50 subjects per subgroup, who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. Subgroups include pediatric patients in the following age ranges: subgroup 1: 2-5 years old, subgroup 2: 6-11 years old, subgroup 3: 12-21 years old.
After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential (12 years or older) will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study.
Patients will undergo their PSG test while simultaneously wearing 2 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the Wesper Lab device and collect the sleep data via the companion smartphone application.
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events.
Following the data collection, sleep data from PSG and Wesper Lab will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the Wesper Lab data to obtain an estimate of inter-rater reliability.
Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal. The performance goal is based on a meta-analysis of FDA-cleared similar devices. Fisher's transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0.025. The upper and lower 95% Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices. Deming regression will also be presented. The inter-rater reliability of Wesper Lab AHIs will be calculated.
- Being tested
- Medical Device: Wesper Lab Home Sleep Test
- Keywords
- Sleep Apnea, Pediatric Sleep Apnea, Home Sleep Test, Sleep Disordered Breathing
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device: Wesper Lab Home Sleep TestDevice
Wesper Lab is a medical device that is used for the diagnosis of sleep apnea. Wesper lab is composed of two flexible biosensors that adhere to the abdomen and thorax with medical grade adhesive. A FDA approved pulse oximeter is worn on a finger.
| Study group | Role | What they receive |
|---|---|---|
| Medical Device: Wesper Lab (Single Arm) | Experimental | Participants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device. Receives: Device: Medical Device: Wesper Lab Home Sleep Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).
The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.
The primary outcome measure of this study is to determine there is sufficient agreement between the AHI measured by Wesper Lab with the AHI measured by PSG.
Measured: 8 hours
Secondary outcomes (1)
Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.
The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.
Sleep apnea severity is calculated with AHI as determined by the American Academy of Sleep Medicine.
Normal: AHI = 0 - 4.99 Mild: AHI = 5 - 14.99 Moderate: AHI = 15 - 29.99 Severe: AHI = >30
The secondary outcome measure is to determine there is sufficient agreement between the sleep apnea severity measured by Wesper Lab with the sleep apnea severity measured by PSG.
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 posted23 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Medical device, single arm. All subjects will be provided with the same medical device (Wesper Lab), a home sleep test.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wesper Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- German P Digoy, M.D., Principal investigator, Associate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218186
- Sponsor's protocol ID
- WSP-111
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Raphelson JR, Ahmed IM, Ancoli-Israel S, Ojile J, Pearson S, Bennett N, Uhles ML, Rohrscheib C, Malhotra A. Evaluation of a novel device to assess obstructive sleep apnea and body position. J Clin Sleep Med. 2023 Sep 1;19(9):1643-1649. doi: 10.5664/jcsm.10644.
PubMed 37140998Zandieh S, Kirschenbaum MA, Greenberg H, Ancoli-Israel S. Keep it simple: A novel technique for measuring airflow using a wireless patch. Sleep Health. 2023 Feb;9(1):100-107. doi: 10.1016/j.sleh.2022.10.005. Epub 2022 Dec 5.
PubMed 36473786
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations
- ClinicalTrials.gov ID
- NCT06218186
- Acronym / sponsor ID
- WSP-111
- Keywords
- Sleep Apnea, Pediatric Sleep Apnea, Home Sleep Test, Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wesper IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Jan 2024 (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 single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age).
The main question[s] it aims to answer are:
- Does Wesper Lab demonstrate agreement with PSG for the calculation of the apnea/hypopnea index (AHI)?
- Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity.
Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter.
Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device.
This is a single center, single-arm, quantitative study
Detailed description
This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population.
Investigators will identify approximately 150 eligible pediatric patients, 50 subjects per subgroup, who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. Subgroups include pediatric patients in the following age ranges: subgroup 1: 2-5 years old, subgroup 2: 6-11 years old, subgroup 3: 12-21 years old.
After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential (12 years or older) will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study.
Patients will undergo their PSG test while simultaneously wearing 2 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the Wesper Lab device and collect the sleep data via the companion smartphone application.
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events.
Following the data collection, sleep data from PSG and Wesper Lab will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the Wesper Lab data to obtain an estimate of inter-rater reliability.
Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal. The performance goal is based on a meta-analysis of FDA-cleared similar devices. Fisher's transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0.025. The upper and lower 95% Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices. Deming regression will also be presented. The inter-rater reliability of Wesper Lab AHIs will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medical device, single arm. All subjects will be provided with the same medical device (Wesper Lab), a home sleep test.
| Arm | Type | Receives |
|---|---|---|
| Medical Device: Wesper Lab (Single Arm) | Experimental | Device: Medical Device: Wesper Lab Home Sleep TestParticipants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be 2 to 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.
- If 18 years or older, be able to willingly sign a written informed consent form prior to the initiation of any study procedure. If younger than 18 years of age, have a parent or legal guardian 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)
- Individuals younger than 2 years of age.
- Individuals older than 21 years of age
- Females 12 years or older who have a positive urine pregnancy test on the day of the study.
- 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 |
|---|---|---|
| Medical Device: Wesper Lab Home Sleep TestWesper Lab is a medical device that is used for the diagnosis of sleep apnea. Wesper lab is composed of two flexible biosensors that adhere to the abdomen and thorax with medical grade adhesive. A FDA approved pulse oximeter is worn on a finger. | Device | Medical Device: Wesper Lab (Single Arm) |
Primary outcome
Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).
Time frame: 8 hours
The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine. The primary outcome measure of this study is to determine there is sufficient agreement between the AHI measured by Wesper Lab with the AHI measured by PSG.
1 secondary outcome
Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 37140998Raphelson JR, Ahmed IM, Ancoli-Israel S, Ojile J, Pearson S, Bennett N, Uhles ML, Rohrscheib C, Malhotra A. Evaluation of a novel device to assess obstructive sleep apnea and body position. J Clin Sleep Med. 2023 Sep 1;19(9):1643-1649. doi: 10.5664/jcsm.10644.
- Results publication: PubMed 36473786Zandieh S, Kirschenbaum MA, Greenberg H, Ancoli-Israel S. Keep it simple: A novel technique for measuring airflow using a wireless patch. Sleep Health. 2023 Feb;9(1):100-107. doi: 10.1016/j.sleh.2022.10.005. Epub 2022 Dec 5.
- Investigational DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Amir Reuveny, Ph.D contact
German P Digoy, M.D. principal investigator
Associate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device: Wesper Lab Home Sleep Test in people with Sleep Apnea and Sleep Apnea Syndromes in Children, run by Wesper Inc at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chelsie E Rohrscheib, Ph.D (18106236374, chelsie@wesper.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI). (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218186, which also lists 2 linked publications.
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 23 Jan 2024.