Sleep Apnea SyndromesWPATNCT03188718
WatchPAT Device Validation Study Compared to Polysomnography
A study testing WatchPAT Intervention in people with Sleep Apnea Syndromes and Sleep Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Validation study of a novel sleep Device compared to a traditional sleep study. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- What is being tested?
- WatchPAT Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5 through 12 years of age.
- Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
- snoring,
- witnessed apneas,
- daytime sleepiness, and
- mouth breathing, etc.
- Informed consent obtained.
Who cannot join
- Medical conditions that can affect the tonometer reading such as:
- peripheral vascular disease,
- cyanotic heart disease,
- systemic hypertension, and
- sickle cell crisis.
- Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
Show all 13Show fewer
- autism spectrum disorder,
- Trisomy 21, and
- neurodevelopmental disorders.
- History of neuromuscular malformation
- History of current supplemental oxygen use
- History of current vasoactive, cardiac or seizure medication use
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age
Validation study of a novel sleep Device compared to a traditional sleep study.
Read the detailed description
This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.
- Conditions
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- Being tested
- WatchPAT Intervention
- Keywords
- Polysomnogram, Sleep Disordered Breathing
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WatchPAT InterventionDevice
Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.
| Study group | Role | What they receive |
|---|---|---|
| WatchPAT Intervention | Other | Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). Receives: Device: WatchPAT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.
Measured: Up to 10 hours
Secondary outcomes (8)
Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)
Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep.
Measured: Up to 10 hours
Oxygen Desaturation Index (ODI)
Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.
Measured: Up to 10 hours
Sleep Staging: Light and Deep
Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).
Measured: Up to 10 hours
Oxygen Saturation
Amount of oxygen present in the subjects blood via pulse oximetry.
Measured: Up to 10 hours
Heart Rate
Documentation of the Subjects heart rate.
Measured: Up to 10 hours
Body Position
Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.
Measured: Up to 10 hours
Sleep Time (Total)
The Total Sleep Duration time in minutes as recorded by the PSG.
Measured: Up to 10 hours
Sleep Staging: REM
Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start7 Dec 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Itamar-Medical, Israel
- Responsible party
- Sponsor
- Investigators
- Michelle Sobremonte-King, MD, Principal investigator, University of Colorado, DenverAnn Halbower, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188718
- Sponsor's protocol ID
- 17-0827
- Acronym
- WPAT
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2017
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age
- ClinicalTrials.gov ID
- NCT03188718
- Acronym / sponsor ID
- WPAT / 17-0827
- Conditions
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- Keywords
- Polysomnogram, Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Itamar-Medical, Israel
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 21 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation study of a novel sleep Device compared to a traditional sleep study.
Detailed description
This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WatchPAT Intervention | Other | Device: WatchPAT InterventionWearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 5 through 12 years of age.
- Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
- Informed consent obtained.
Key exclusion criteria (13 listed)
- Medical conditions that can affect the tonometer reading such as:
- Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
- History of neuromuscular malformation
- History of current supplemental oxygen use
- History of current vasoactive, cardiac or seizure medication use
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 |
|---|---|---|
| WatchPAT InterventionWearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram. | Device | WatchPAT Intervention |
Primary outcome
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
Time frame: Up to 10 hours
Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.
8 secondary outcomes
Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)
Time frame: Up to 10 hours
Oxygen Desaturation Index (ODI)
Time frame: Up to 10 hours
Sleep Staging: Light and Deep
Time frame: Up to 10 hours
Oxygen Saturation
Time frame: Up to 10 hours
Heart Rate
Time frame: Up to 10 hours
Body Position
Time frame: Up to 10 hours
Sleep Time (Total)
Time frame: Up to 10 hours
Sleep Staging: REM
Time frame: Up to 10 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Michelle Sobremonte-King, MD principal investigator
University of Colorado, Denver
Ann Halbower, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WatchPAT Intervention in people with Sleep Apnea Syndromes and Sleep Disorder, run by University of Colorado, Denver 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 7 inclusion and 13 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 21 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) (time frame: Up to 10 hours). 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 21 Apr 2021.