Measuring Breathing Airflow Using a Heat Sensitive Camera (ThermFlow)

NCT05972161 | Completed

• 1 other identifier: SCH-2173
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  10 months

Secondary Outcomes (2)

• How successful are nasal sensors in an overnight study. Data downloaded on a software system

  10 months

• How Successful is Thermal Imaging overnight. Data downloaded on a software system

  10 months

Interventions

Thermal Imaging camera DEVICE

Thermal Imaging camera used to measure respiratory flow.

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

CRF, Sheffield Childrens Hospital

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Heather Elphick

  Sheffield Childrens NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: August 2, 2023
• Study Start: October 24, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: August 2, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)