Obstructive Sleep ApneaNCT03544086
Clinical Evaluation of a Wearable Sleep Diagnosis Technology
An observational study of Obstructive Sleep Apnea, run by Acurable Ltd. at 1 site in United Kingdom.
Trial summary
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2018to 15 Sep 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea, consecutive 160 patients coming to the clinic.
Who may be able to join
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Who cannot join
- Age under 18 or over 70 years.
- Subjects who are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- Subjects with physical or mental impairments who would not be able to use the new technology on their own.
- Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
- Subjects with pacemakers.
- exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).
Trial locations and contacts
1 site in 1 country.
About this study
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
Read the detailed description
The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.
Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.
- Conditions
- Obstructive Sleep Apnea
- 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.
| Study group | Role | What they receive |
|---|---|---|
| test group | First group is the first 10 patients | |
| study group | following 150 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start10 Jul 2018
- Primary completion30 Dec 2019
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acurable Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD, Principal investigator, Royal Free NHS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544086
- Sponsor's protocol ID
- 225818
- Other IDs
- 225818
- Status last verified
- Dec 2020
- First submitted
- 22 May 2018
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.
PubMed 34933855
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Wearable Sleep Diagnosis Technology
- ClinicalTrials.gov ID
- NCT03544086
- Acronym / sponsor ID
- 225818
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Acurable Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 1 Jun 2018 (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.
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
Detailed description
The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.
Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | –First group is the first 10 patients |
| study group | – | –following 150 patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea, consecutive 160 patients coming to the clinic.
Key inclusion criteria (1 listed)
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Key exclusion criteria (7 listed)
- Age under 18 or over 70 years.
- Subjects who are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- Subjects with physical or mental impairments who would not be able to use the new technology on their own.
- Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
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
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Time frame: 6 months
Sensitivities and Specificities for diagnosis of sleep apnoea studies
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 4 Dec 2020.
- Derived from this study: PubMed 34933855Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.
- 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.
Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD principal investigator
Royal Free NHS 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 Obstructive Sleep Apnea, run by Acurable Ltd. 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 1 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 4 Dec 2020. 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?
Sensitivities and Specificities for diagnosis of sleep apnoea studies (time frame: 6 months). 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 NCT03544086, which also lists 1 linked publication.
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 4 Dec 2020.