Sleep ApneaThermFlowNCT05972161
Measuring Breathing Airflow Using a Heat Sensitive Camera (ThermFlow)
An observational study of Sleep Apnea, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics. This research utilises thermal imaging techniques to detect fractures, arthritic inflammation and infection. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Thermal Imaging camera
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2017to 26 Jun 2018
- 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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
Who may be able to join
- Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
Who cannot join
- Families who do not understand written or verbal English where no interpreter is present
- Children who do not attend with their parent / legal guardian and so are therefore unable to give informed consent
- Children who are undergoing tracheostomy or ventilation sleep studies and so will not be expected to wear nasal airflow sensors during their sleep study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CRF, Sheffield Childrens Hospital
Sheffield, S10 2TH
About this study
Official title: High Resolution Thermal Imaging Developments for Non-Contact Airflow Measurement: A Novel Child-friendly Method to Monitor Paediatric Airflow.
ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics. This research utilises thermal imaging techniques to detect fractures, arthritic inflammation and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development of techniques that has led to the current research study. The purpose of this study is to develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric airflow.
Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate paediatric sleep-related breathing disorders. 1-6% of children have problems with their breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number of physiological parameters are measured. These include heart rate, chest movements, airflow, oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached to the child whilst awake, and then the child settles to sleep. Airflow parameters are measured by two contact sensors; one measures airflow by temperature and the other measures airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be attached or removed them immediately causing difficulties in interpreting their condition.
Breathing generates changes in temperature around nose and mouth which can be detected with HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The investigators will compare airflow measurements from the existing clinical nasal sensors and HRTI to evaluate whether this new technique will provide an accurate non-contact alternative to measure respiration airflow.
Read the detailed description
The study will form part of a wider project currently ongoing which is looking into development of HRTI for clinical diagnosis and monitoring. It builds on the significant progress the investigators made through the ThermPaed study. Sheffield Hallam University supports this study by allocating an MPhil student (UR). The student will be jointly supervised at the University by Professor Saatchi who is well-established in digital signal and image processing and Professor Elphick and Dr Kingshott.
This study design is explained below. Measurement of thermal imaging alongside standard clinical parameters Following ethics and HRA approval, the investigators will identify 30 suitable children attending Sheffield Children's Hospital Sleep Unit who are undergoing cardiorespiratory PSG investigation for sleep-related breathing disorders.
Each patient would undergo the standard diagnostic cardiorespiratory PSG and wear all the sensors as usual. In addition, following consent, HRTI will be performed in the Sleep Unit overnight. The HRTI device will be positioned alongside the standard video camera used in PSG. The standard recording time of a PSG study is between 8-12 hours and is determined by the child and their age-related sleep and wake times. Even if the child does not tolerate the nasal sensors, the investigators will record HRTI to identify potentially missed apnoea events. The study therefore does not interfere in any way with the patient's normal procedures.
Patient, carer and staff opinions of the HRTI versus conventional nasal sensors.
As part of the research, the participating children, their attending carer and overnight sleep nursing staff will complete an evaluation questionnaire [Appendix 1] in the morning following the PSG.
Development of software to integrate the HRTI data with the PSG sleep system
The HRTI data recording and processing will be carried out by the MPhil student, supervised by his university tutor. The data will be stored on a password secure laptop during the recording and then transferred and stored in a safe, secure and password protected drive at Sheffield Hallam University. Each participating patient will be assigned a unique identifying number (see sections 5.3 and 6.0). There will not be any identifiable patient information with these recordings. The PSG data are downloaded onto a sleep software system at the hospital and then the anonymised version of the airflow signals will be stored at Sheffield Hallam University research secure drive. This sleep software has the ability to export its data anonymously and so currently can be integrated alongside the HRTI data. Workflow on integrating these two sets of data will include:
- Discussion with the sleep software company to directly integrate the thermal imaging data into the sleep software.
- Time synchronising the two data sets. Blinded scoring analysis of the signals to compare apnoea event scoring and classification Once each child's data are collected, Dr Kingshott will interpret the PSG data to identify apnoea events. Following standard AASM scoring guidelines apnoeas will be marked using the nasal sensor channels versus the HRTI channel. In order to minimise scoring bias, the processing order for HRTI versus the data from the nasal sensors will be randomised.
- Conditions
- Sleep Apnea
- Being tested
- Thermal Imaging camera
- 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.
Thermal Imaging cameraDevice
Thermal Imaging camera used to measure respiratory flow.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system
Agreement between the apnoeas measured by HRTI and the apnoeas measured by nasal sensors.
Measured: 10 months
Secondary outcomes (2)
How successful are nasal sensors in an overnight study. Data downloaded on a software system
Success rates of nasal sensors in situ overnight
Measured: 10 months
How Successful is Thermal Imaging overnight. Data downloaded on a software system
Success rates of HRTI image in frame overnight
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start24 Oct 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Elphick, Principal investigator, Sheffield Childrens NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972161
- Sponsor's protocol ID
- SCH-2173
- Acronym
- ThermFlow
- Status last verified
- Dec 2019
- First submitted
- 15 Jun 2018
- Last updated
- 2 Aug 2023
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Thermal Imaging Developments for Non-Contact Airflow Measurement: A Novel Child-friendly Method to Monitor Paediatric Airflow.
- ClinicalTrials.gov ID
- NCT05972161
- Acronym / sponsor ID
- ThermFlow / SCH-2173
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 2 Aug 2023 (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.
ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics. This research utilises thermal imaging techniques to detect fractures, arthritic inflammation and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development of techniques that has led to the current research study. The purpose of this study is to develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric airflow.
Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate paediatric sleep-related breathing disorders. 1-6% of children have problems with their breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number of physiological parameters are measured. These include heart rate, chest movements, airflow, oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached to the child whilst awake, and then the child settles to sleep. Airflow parameters are measured by two contact sensors; one measures airflow by temperature and the other measures airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be attached or removed them immediately causing difficulties in interpreting their condition.
Breathing generates changes in temperature around nose and mouth which can be detected with HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The investigators will compare airflow measurements from the existing clinical nasal sensors and HRTI to evaluate whether this new technique will provide an accurate non-contact alternative to measure respiration airflow.
Detailed description
The study will form part of a wider project currently ongoing which is looking into development of HRTI for clinical diagnosis and monitoring. It builds on the significant progress the investigators made through the ThermPaed study. Sheffield Hallam University supports this study by allocating an MPhil student (UR). The student will be jointly supervised at the University by Professor Saatchi who is well-established in digital signal and image processing and Professor Elphick and Dr Kingshott.
This study design is explained below. Measurement of thermal imaging alongside standard clinical parameters Following ethics and HRA approval, the investigators will identify 30 suitable children attending Sheffield Children's Hospital Sleep Unit who are undergoing cardiorespiratory PSG investigation for sleep-related breathing disorders.
Each patient would undergo the standard diagnostic cardiorespiratory PSG and wear all the sensors as usual. In addition, following consent, HRTI will be performed in the Sleep Unit overnight. The HRTI device will be positioned alongside the standard video camera used in PSG. The standard recording time of a PSG study is between 8-12 hours and is determined by the child and their age-related sleep and wake times. Even if the child does not tolerate the nasal sensors, the investigators will record HRTI to identify potentially missed apnoea events. The study therefore does not interfere in any way with the patient's normal procedures.
Patient, carer and staff opinions of the HRTI versus conventional nasal sensors.
As part of the research, the participating children, their attending carer and overnight sleep nursing staff will complete an evaluation questionnaire [Appendix 1] in the morning following the PSG.
Development of software to integrate the HRTI data with the PSG sleep system
The HRTI data recording and processing will be carried out by the MPhil student, supervised by his university tutor. The data will be stored on a password secure laptop during the recording and then transferred and stored in a safe, secure and password protected drive at Sheffield Hallam University. Each participating patient will be assigned a unique identifying number (see sections 5.3 and 6.0). There will not be any identifiable patient information with these recordings. The PSG data are downloaded onto a sleep software system at the hospital and then the anonymised version of the airflow signals will be stored at Sheffield Hallam University research secure drive. This sleep software has the ability to export its data anonymously and so currently can be integrated alongside the HRTI data. Workflow on integrating these two sets of data will include:
- Discussion with the sleep software company to directly integrate the thermal imaging data into the sleep software.
- Time synchronising the two data sets. Blinded scoring analysis of the signals to compare apnoea event scoring and classification Once each child's data are collected, Dr Kingshott will interpret the PSG data to identify apnoea events. Following standard AASM scoring guidelines apnoeas will be marked using the nasal sensor channels versus the HRTI channel. In order to minimise scoring bias, the processing order for HRTI versus the data from the nasal sensors will be randomised.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
Key inclusion criteria (1 listed)
- Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
Key exclusion criteria (3 listed)
- Families who do not understand written or verbal English where no interpreter is present
- Children who do not attend with their parent / legal guardian and so are therefore unable to give informed consent
- Children who are undergoing tracheostomy or ventilation sleep studies and so will not be expected to wear nasal airflow sensors during their sleep study
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 |
|---|---|---|
| Thermal Imaging cameraThermal Imaging camera used to measure respiratory flow. | Device | – |
Primary outcome
Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system
Time frame: 10 months
Agreement between the apnoeas measured by HRTI and the apnoeas measured by nasal sensors.
2 secondary outcomes
How successful are nasal sensors in an overnight study. Data downloaded on a software system
Time frame: 10 months
How Successful is Thermal Imaging overnight. Data downloaded on a software system
Time frame: 10 months
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 2 Aug 2023.
- 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.
Heather Elphick principal investigator
Sheffield Childrens NHS Foundation Trust
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 Apnea, run by Sheffield Children's 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 1 inclusion and 3 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 2 Aug 2023. 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?
Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system (time frame: 10 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 2 Aug 2023.