Sleep ApneaNCT03120897

Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

A study testing RAM sensor in people with Sleep Apnea, run by Masimo Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population Read more about this study

Who is it for?: Ages Up to 70 years
Conditions the study is for: Sleep Apnea
What is being tested?: RAM sensor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Oct 2018
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 Up to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or Female subjects that are between 0 to 70 years old.
Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

Who cannot join

Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
Patients who the PI deems ineligible at the PI's discretion

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

About this study

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population

Conditions: Sleep Apnea
Being tested: RAM sensor
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.

RAM sensorDevice
Rainbow Acoustic Monitoring sensor for measurement of respiratory rate

Study groups in NCT03120897
Study group	Role	What they receive
Test group	Experimental	The subjects will be enrolled into the test group and will receive RAM sensor. Receives: Device: RAM sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects in which respiratory rate is collected
Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor
Measured: Duration of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Oct 2018

First posted19 Apr 2017
Study startJun 2016
Primary completionOct 2018
Study completionOct 2018

Why it stopped: Sponsor decision to terminate study.

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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03120897
Sponsor's protocol ID: DROV0008
Status last verified: Apr 2021
First submitted: 14 Apr 2017
Last updated: 18 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
ClinicalTrials.gov ID: NCT03120897
Acronym / sponsor ID: DROV0008
Conditions: Sleep Apnea
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to terminate study.
Enrolment: 78 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 19 Apr 2017 (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.

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test group	Experimental	Device: RAM sensorThe subjects will be enrolled into the test group and will receive RAM sensor.

Who may qualify

Ages: Up to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or Female subjects that are between 0 to 70 years old.
Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

Key exclusion criteria (3 listed)

Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
Patients who the PI deems ineligible at the PI's discretion

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
RAM sensorRainbow Acoustic Monitoring sensor for measurement of respiratory rate	Device	Test group

Primary outcome

Number of subjects in which respiratory rate is collected
Time frame: Duration of surgery
Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor

Results and safety

The study was stopped early (reason given: Sponsor decision to terminate study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RAM sensor in people with Sleep Apnea, run by Masimo Corporation 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 May 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?

The study was stopped early (reason given: Sponsor decision to terminate study.). Results are not available in the source record.

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?

Number of subjects in which respiratory rate is collected (time frame: Duration of surgery). 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 NCT03120897.

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 18 May 2021.