Sleep ApneaNCT04031950
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
An observational study of Sleep Apnea, run by Acurable Ltd. at 2 sites in United Kingdom.
Trial summary
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Novel wearable paediatric device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Feb 2020to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all children who have been referred for a sleep test.
Who may be able to join
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Who cannot join
- Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
- Patients with not enough space on the neck area to fit the sensor.
- Clinical problem in the area in which the device will be attached, eg skin condition
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Sheffield Children Hospital
Sheffield, S10 2TH
Orsina Dessi, +447721 877020, orsina@acurable.com
Heather Elphick
- Recruiting
Southampton Children's Hospital
Southampton
Orsina Dessi
Hazel Evans
About this study
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Read the detailed description
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.
At the end of the trial, we will compare the diagnosis results from both systems.
- Conditions
- Sleep Apnea
- Being tested
- Novel wearable paediatric device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel wearable paediatric deviceDevice
The patient will wear the novel wearable paediatric device at the same time as polysmnography
| Study group | Role | What they receive |
|---|---|---|
| test group | Test group will wear PSG Receives: Device: Novel wearable paediatric device | |
| Novel wearable device | THis group will wear the novel device Receives: Device: Novel wearable paediatric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of novel device
specificity and sensitivity of the output of the novel wearable device against polysomnography
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 posted25 Jul 2019
- Study start19 Feb 2020
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acurable Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ruth Kingshott, PhD, Study director, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031950
- Sponsor's protocol ID
- 269747
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2019
- Last updated
- 15 Aug 2025
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
- ClinicalTrials.gov ID
- NCT04031950
- Acronym / sponsor ID
- 269747
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acurable Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 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.
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Detailed description
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.
At the end of the trial, we will compare the diagnosis results from both systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | Device: Novel wearable paediatric deviceTest group will wear PSG |
| Novel wearable device | – | Device: Novel wearable paediatric deviceTHis group will wear the novel device |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all children who have been referred for a sleep test.
Key inclusion criteria (2 listed)
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Key exclusion criteria (5 listed)
- Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
- Patients with not enough space on the neck area to fit the sensor.
- Clinical problem in the area in which the device will be attached, eg skin condition
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 paediatric deviceThe patient will wear the novel wearable paediatric device at the same time as polysmnography | Device | Novel wearable device, test group |
Primary outcome
Specificity and sensitivity of novel device
Time frame: 6 months
specificity and sensitivity of the output of the novel wearable device against polysomnography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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
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.
Ruth Kingshott, PhD study director
Sheffield Children's NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Acurable Ltd. at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Specificity and sensitivity of novel 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 15 Aug 2025.