Sleep ApnoeaNCT04071860
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
An observational study of Sleep Apnoea and Obstructive Sleep Apnoea, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnoea, Obstructive Sleep Apnoea
- How many people
- 445 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2019to 31 Jul 2021
- 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 referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.
Who may be able to join
- Aged 18 years or older
- Able to give informed consent
Who cannot join
- Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.
- Polysomnography study records less than 4 hours of respiratory data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Cambridge, Cambridgeshire, CB2 0AY
About this study
Official title: Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.
- Conditions
- Sleep Apnoea, Obstructive Sleep Apnoea
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| discovery and learning cohort | Data from this cohort will be used to develop the software algorithms | |
| Validation | Data from this cohort will be used to validate the software algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography
Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported.
Measured: overnight (8-10 hours)
Secondary outcomes (2)
Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG
Agreement +/- 1 breath per minute between Safescan device and PSG
Measured: overnight (8-10 hours)
Agreement in recorded body position between Safescan device and PSG
Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG
Measured: overnight (8-10 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Jan 2019
- Primary completion20 Dec 2019
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApnoeaStudies 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
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Iceni Labs Ltd, Warwickshire, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ian Smith, MD, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071860
- Sponsor's protocol ID
- P02423
- Status last verified
- Sep 2022
- First submitted
- 4 Mar 2019
- Last updated
- 28 Sep 2022
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
- ClinicalTrials.gov ID
- NCT04071860
- Acronym / sponsor ID
- P02423
- Conditions
- Sleep Apnoea, Obstructive Sleep Apnoea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Iceni Labs Ltd, Warwickshire, United Kingdom
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 28 Aug 2019 (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.
Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| discovery and learning cohort | – | –Data from this cohort will be used to develop the software algorithms |
| Validation | – | –Data from this cohort will be used to validate the software algorithms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Able to give informed consent
Key exclusion criteria (2 listed)
- Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.
- Polysomnography study records less than 4 hours of respiratory data
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
Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography
Time frame: overnight (8-10 hours)
Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported.
2 secondary outcomes
Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG
Time frame: overnight (8-10 hours)
Agreement in recorded body position between Safescan device and PSG
Time frame: overnight (8-10 hours)
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 28 Sep 2022.
- 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.
Ian Smith, MD principal investigator
Royal Papworth Hospital
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 Apnoea and Obstructive Sleep Apnoea, run by Papworth Hospital NHS Foundation Trust 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 2 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 28 Sep 2022. 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?
Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography (time frame: overnight (8-10 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 28 Sep 2022.