Sleep DisorderNCT06093633
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
An observational study of Sleep Disorder, run by Itamar-Medical, Israel at 3 sites in 2 countries.
Trial summary
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Sleep Disorder
- How many people
- 600 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Sep 2022to 1 Oct 2025
- Phase
- Observational
- 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with suspected sleep disorders or patients with comorbidities that increase the likelihood of central sleep apnea who are referred for a sleep study.
Who may be able to join
- Age between 12-99
- Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory
- Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.
Who cannot join
- Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
- Finger deformity that precludes adequate sensor appliance.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, 21224
Luu Pham, MD, 410-550-2233, luu.pham@jhmi.edu
- Recruiting
University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
Towson, Maryland, 21286
Alan Schwartz, MD, (410) 832-3400 ext. 2218, aschwar02@gmail.com
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Medical Center
Tel Aviv, 6423906
Rivi Tauman, MD, 00972524262025, tauman@tlvmc.gov.il
About this study
Official title: A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.
Read the detailed description
Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.
- Conditions
- Sleep Disorder
- Keywords
- WatchPAT, Polysomnography, ambulatory device, sleep apnea, apnea-hypopnea index
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea- Hypopnea Index (AHI)
Compares the results of the automatically scored AHI of the WP to the manually scored AHI of the PSG (Gold Standard). AHI is the average number of apnea and hypopnea events per hour of sleep
Measured: one night of sleep
Sleep Stages
Compares the results of the automatically scored sleep stages of the WP to the manually scored sleep stages of the PSG (Gold Standard). Stages are light sleep, deep sleep, REM or Wake.
Measured: one night of sleep
Secondary outcomes (1)
Respiratory Disturbance Index (RDI)
Compares the results of the automatically scored RDI of the WP to the manually scored RDI of the PSG (Gold Standard). RDI is the average number of respiratory events per hour of sleep
Measured: one night of sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Sep 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Itamar-Medical, Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rivi Tauman, Prof,, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093633
- Sponsor's protocol ID
- WP-001
- Status last verified
- Aug 2025
- First submitted
- 12 Oct 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
- ClinicalTrials.gov ID
- NCT06093633
- Acronym / sponsor ID
- WP-001
- Conditions
- Sleep Disorder
- Keywords
- WatchPAT, Polysomnography, ambulatory device, sleep apnea, apnea-hypopnea index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Itamar-Medical, IsraelIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Oct 2023 (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 current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.
Detailed description
Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with suspected sleep disorders or patients with comorbidities that increase the likelihood of central sleep apnea who are referred for a sleep study.
Key inclusion criteria (3 listed)
- Age between 12-99
- Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory
- Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.
Key exclusion criteria (2 listed)
- Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
- Finger deformity that precludes adequate sensor appliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea- Hypopnea Index (AHI)
Time frame: one night of sleep
Compares the results of the automatically scored AHI of the WP to the manually scored AHI of the PSG (Gold Standard). AHI is the average number of apnea and hypopnea events per hour of sleep
Sleep Stages
Time frame: one night of sleep
Compares the results of the automatically scored sleep stages of the WP to the manually scored sleep stages of the PSG (Gold Standard). Stages are light sleep, deep sleep, REM or Wake.
1 secondary outcome
Respiratory Disturbance Index (RDI)
Time frame: one night of sleep
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Rivi Tauman, Prof, principal investigator
Tel Aviv Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, run by Itamar-Medical, Israel at 3 sites in 2 countries.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. 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?
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 Ravit Roytman (00972545456819, ravit.lusky@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea- Hypopnea Index (AHI) (time frame: one night of sleep). 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 22 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.