Clinical Evaluation of a Paediatric Sleep Diagnosis Techn... | NCT04031950

Studies
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

NCT04031950

Sponsor

Acurable Ltd.

Status

Recruiting

Last Update Posted

Aug 15, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Sleep Apnea

Interventions

Novel wearable paediatric device

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2020Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2025

Last Update Posted Date

Aug 15, 2025Actual

Name	Class
Sheffield Children's NHS Foundation Trust	OTHER
University Hospital Southampton NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test group		Test group will wear PSG	Device: Novel wearable paediatric device
Novel wearable device		THis group will wear the novel device	Device: Novel wearable paediatric device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novel wearable paediatric device	Device	The patient will wear the novel wearable paediatric device at the same time as polysmnography	Novel wearable device test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Specificity and sensitivity of novel device	specificity and sensitivity of the output of the novel wearable device against polysomnography	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children older than one year old
Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

all children who have been referred for a sleep test.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orsina Dessi, MEng	Contact	+447721 877020		orsina@acurable.com

Overall Officials

Name	Affiliation	Role
Ruth Kingshott, PhD	Sheffield Children's NHS Foundation Trust	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheffield Children Hospital	Recruiting	Sheffield		S10 2TH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided