An observational study in Sleep Apnea, sponsored by Sheffield Children's NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 0 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Sheffield Children's NHS Foundation Trust · Observational
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.
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:
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's enrollment of 30 is below the median of 109 across 659 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Sheffield Children's NHS Foundation Trust is the lead sponsor of 52 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Thermal Imaging camera used to measure respiratory flow.
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.
Time frame: 10 months
How successful are nasal sensors in an overnight study. Data downloaded on a software system
Success rates of nasal sensors in situ overnight
Time frame: 10 months
How Successful is Thermal Imaging overnight. Data downloaded on a software system
Success rates of HRTI image in frame overnight
Time frame: 10 months
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Sheffield Children's NHS Foundation Trust