Sleep Disorder; Breathing-RelatedNCT04249011
WatchPAT Compared to PSG at 8500'
An observational study of Sleep Disorder; Breathing-Related, run by Itamar-Medical, Israel at 1 site in United States.
Trial summary
Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder; Breathing-Related
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 10 Dec 2019
- Phase
- Observational
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects referred to a sleep lab for full PSG.
Who may be able to join
- Male and females ≥ age 17yrs
- Subject is able to read understand and sign the informed consent form.
- Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.
Who cannot join
- Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
- Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Sleep Diagnostics
Woodland Park, Colorado, 80863
About this study
Official title: Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.
Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.
Read the detailed description
The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"
- Conditions
- Sleep Disorder; Breathing-Related
- Medical subject headings
- Sleep Wake Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
Measured: 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start2 May 2018
- Primary completion14 Aug 2018
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder; Breathing-RelatedStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Itamar-Medical, Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koby Sheffy, Phd, Study director, Itamar-Medical, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249011
- Sponsor's protocol ID
- WP200U-Altitude-001
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.
- ClinicalTrials.gov ID
- NCT04249011
- Acronym / sponsor ID
- WP200U-Altitude-001
- Conditions
- Sleep Disorder; Breathing-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Itamar-Medical, IsraelIndustry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 30 Jan 2020 (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.
Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.
Detailed description
The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects referred to a sleep lab for full PSG.
Key inclusion criteria (3 listed)
- Male and females ≥ age 17yrs
- Subject is able to read understand and sign the informed consent form.
- Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.
Key exclusion criteria (2 listed)
- Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before 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.
Primary outcome
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
Time frame: 8 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
Related trials for Sleep Disorder; Breathing-Related
Recruiting
IOA Preventing Occlusal Changes With MAD Use
Sleep Related Breathing Disorder, Snoring
Not yet recruitingObservational study
Oral Health, Dento-facial Condition and OHRQoL in Subjects With Mowat-Wilson Syndrome: an Epidemiologic Study.
Mowat-Wilson Syndrome, Dental Caries
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
Active, not recruiting
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
Sleep Disorder; Breathing-Related, Central Apnea
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.
Koby Sheffy, Phd study director
Itamar-Medical, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder; Breathing-Related, run by Itamar-Medical, Israel 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 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: finished, as of the sponsor's last update on 30 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG. (time frame: 8 months.). 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 30 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.