Respiratory RateNCT03149744
Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor
An observational study of Respiratory Rate, run by PMD Solutions at 1 site in United Kingdom.
Trial summary
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea. With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- RespiraSense Sleep Screener
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2017to 2 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients due to undergo standard of care home sleep testing
Who may be able to join
- Patients ≥ 18 Years
- Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
- Patients able to provide informed consent to participate in this investigation
Who cannot join
- Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
- Patients allergic to medical grade skin adhesive
- Patients on long term, oral steroid use
- Pregnant women during second and third trimester
- Patients presently on any sleep disorder therapy
- Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.
With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.
Read more
The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.
Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.
If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.
- Conditions
- Respiratory Rate
- Being tested
- RespiraSense Sleep Screener
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespiraSense Sleep ScreenerDevice
RespiraSense will be worn at the same time as the standard of care SomnoScreen and it's results will be masked to the site team
What is being measured
The primary outcome is the main question the study is designed to answer.
Similarity to standard of care
The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI
Measured: One night
Secondary outcomes (1)
Qualitative evaluation of RespiraSense
to qualitatively evaluate the perceptions, values and opinions of the RS Sleep Screener device compared with the comparator to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start28 Feb 2017
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMD Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Anoop Chauhan, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149744
- Sponsor's protocol ID
- PMD-CS-008
- Status last verified
- Aug 2018
- First submitted
- 9 May 2017
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
- ClinicalTrials.gov ID
- NCT03149744
- Acronym / sponsor ID
- PMD-CS-008
- Conditions
- Respiratory Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- PMD SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 11 May 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.
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.
With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.
The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.
Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.
If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients due to undergo standard of care home sleep testing
Key inclusion criteria (3 listed)
- Patients ≥ 18 Years
- Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
- Patients able to provide informed consent to participate in this investigation
Key exclusion criteria (7 listed)
- Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
- Patients allergic to medical grade skin adhesive
- Patients on long term, oral steroid use
- Pregnant women during second and third trimester
- Patients presently on any sleep disorder therapy
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 |
|---|---|---|
| RespiraSense Sleep ScreenerRespiraSense will be worn at the same time as the standard of care SomnoScreen and it's results will be masked to the site team | Device | – |
Primary outcome
Similarity to standard of care
Time frame: One night
The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI
1 secondary outcome
Qualitative evaluation of RespiraSense
Time frame: One night
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 29 Aug 2018.
- 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.
Anoop Chauhan principal investigator
Portsmouth Hospitals NHS Trust
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 Respiratory Rate, run by PMD Solutions at 1 site in United Kingdom.
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 7 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 29 Aug 2018. 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 Kingdom. 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?
Similarity to standard of care (time frame: One night). 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 29 Aug 2018.