Obstructive Sleep ApneaNCT04028011
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
An observational study of Obstructive Sleep Apnea, run by Acurable Ltd. at 1 site in Spain.
Trial summary
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Novel Wearable device
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2019to 30 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred for suspicion of sleep apnoea
Who may be able to join
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
- patients between the age of 18 yo and 80 yo
Who cannot join
- who are not fluent in Spanish, or who have special communication needs.
- Known allergy to the adhesive dressing.
- patients with physical or mental impairments who would not be able to use the new technology on their own.
- patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
- patients with pacemakers or who have any type of implanted electronic device
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen Macarena Sevilla
Seville
Jesus Gomez Sanchez, Dr, orsina@acurable.com
About this study
Official title: Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
Read the detailed description
This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Novel Wearable device
- 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.
Novel Wearable deviceDiagnostic test
patient will wear novel wearable device overnight along with normal standard of care
| Study group | Role | What they receive |
|---|---|---|
| PSG and novel wearable device | 75 patients will wear polysomnography at the same time as the Novel wearable device Receives: Diagnostic Test: Novel Wearable device | |
| PG and novel wearable device | 75 patients will wear polygraphy at the same time as the novel wearable device Receives: Diagnostic Test: Novel Wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device
The study aims to compare the diagnosis result of the novel wearable device against standard of care
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 posted22 Jul 2019
- Study start30 Sep 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Acurable Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Sponsor
- Investigators
- Jesus Fernando Sanchez Gomez, MD, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028011
- Sponsor's protocol ID
- 720/19/EC
- Status last verified
- Apr 2024
- First submitted
- 18 Jul 2019
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño
- ClinicalTrials.gov ID
- NCT04028011
- Acronym / sponsor ID
- 720/19/EC
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Acurable Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Jul 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.
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
Detailed description
This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSG and novel wearable device | – | Diagnostic Test: Novel Wearable device75 patients will wear polysomnography at the same time as the Novel wearable device |
| PG and novel wearable device | – | Diagnostic Test: Novel Wearable device75 patients will wear polygraphy at the same time as the novel wearable device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred for suspicion of sleep apnoea
Key inclusion criteria (2 listed)
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
- patients between the age of 18 yo and 80 yo
Key exclusion criteria (5 listed)
- who are not fluent in Spanish, or who have special communication needs.
- Known allergy to the adhesive dressing.
- patients with physical or mental impairments who would not be able to use the new technology on their own.
- patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
- patients with pacemakers or who have any type of implanted electronic device
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 |
|---|---|---|
| Novel Wearable devicepatient will wear novel wearable device overnight along with normal standard of care | Diagnostic test | PG and novel wearable device, PSG and novel wearable device |
Primary outcome
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device
Time frame: 6 months
The study aims to compare the diagnosis result of the novel wearable device against standard of care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
Jesus Fernando Sanchez Gomez, MD principal investigator
Hospital Universitario Virgen Macarena
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 Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orsina Dessi, MEng (+447721 877020, orsina@acurable.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device (time frame: 6 months). 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 17 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.