Obstructive Sleep ApneaPhase 3PMP-300ENCT01364740

PMP-300E (Smart Watch): Portable Monitoring Device Study

A Phase 3 study testing PMP-300E and In-lab PSG in people with Obstructive Sleep Apnea, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: PMP-300E and In-lab PSG
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Jun 2008to Jun 2012
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 and over.
Require a sleep diagnostic study by physician's order.
Able and willing to provide written informed consent.
Able to speak and read English.

Who cannot join

Participation in another interventional research study within the last 30 days.
Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
Consumption of ethanol more than 4 nights per week. (CAGE criteria)
Use of recreational drug within the past 12 months.
Women who are pregnant or currently lactating.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Human Sleep Research
Redwood City, California, 94063
Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Read the detailed description

The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.

Conditions: Obstructive Sleep Apnea
Being tested: PMP-300E, In-lab PSG
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PMP-300EDevice
Also called SmartWatch, Portable Monitoring Device, Sleep Apnea, Home Study
Data collected from Level 3 device
In-lab PSGDevice
Also called Sleep Study
Data collected from Type I In-Lab Polysomnography

Study groups in NCT01364740
Study group	Role	What they receive
PMP-300E, In-Lab PSG	Experimental	PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study) Receives: Device: PMP-300E; Device: In-lab PSG

What is being measured

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

AHI
Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.
Measured: One night

Secondary outcomes (3)

Apnea Index
Number of events/hour of sleep
Measured: One night
Hypopnea Index
Number of events/hour of sleep. Hypopneas scored without EEG arousals.
Measured: One night
Oxygen Saturation
Mean oxygen saturation
Measured: One night

Timeline

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

Jun 2008Jun 2012

First posted2 Jun 2011 (estimated)
Study startJun 2008
Primary completionMay 2012
Study completionJun 2012

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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01364740
Sponsor's protocol ID: SU-04212009-2358
Other IDs: K073327, SPO 42154, eProtocol 13181
Acronym: PMP-300E
Status last verified: Dec 2016
First submitted: 31 May 2011
Last updated: 27 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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

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
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
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
ClinicalTrials.gov ID: NCT01364740
Acronym / sponsor ID: PMP-300E / SU-04212009-2358
Conditions: Obstructive Sleep Apnea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Jun 2008
Primary completion: May 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 2 Jun 2011 (estimated)
Results: Posted 27 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Detailed description

Study design

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

Arm	Type	Receives
PMP-300E, In-Lab PSG	Experimental	Device: PMP-300E, Device: In-lab PSGPMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 and over.
Require a sleep diagnostic study by physician's order.
Able and willing to provide written informed consent.
Able to speak and read English.

Key exclusion criteria (6 listed)

Participation in another interventional research study within the last 30 days.
Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
Consumption of ethanol more than 4 nights per week. (CAGE criteria)
Use of recreational drug within the past 12 months.

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
PMP-300EAlso: SmartWatch, Portable Monitoring Device, Sleep Apnea, Home StudyData collected from Level 3 device	Device	PMP-300E, In-Lab PSG
In-lab PSGAlso: Sleep StudyData collected from Type I In-Lab Polysomnography	Device	PMP-300E, In-Lab PSG

Primary outcome

AHI
Time frame: One night
Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

3 secondary outcomes

Apnea Index
Time frame: One night
Hypopnea Index
Time frame: One night
Oxygen Saturation
Time frame: One night

Results and safety

Results posted to the registry on 27 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SmartWatch PMP-300E	10	10

Primary outcome: AHI

Time frame: One night. Mean (Standard Deviation). Unit: events/hour

Measure	PMP-300E, In-Lab Polysomnography n = 10
PMP-300E	19.2 (14.50)
In-Lab PSG	19.3 (14.5)

PMP-300E, In-Lab Polysomnography: p >0.05, Sign test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PMP-300E, In-Lab Polysomnography	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Obstructive Sleep Apnea

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
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
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep 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.

Clete A. Kushida M.D., Ph.D. principal investigator

Stanford University

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PMP-300E and In-lab PSG in people with Obstructive Sleep Apnea, run by Stanford University at 2 sites 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 6 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2017). 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?

AHI (time frame: One night). 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 NCT01364740.

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 27 Jan 2017.