The relationship between the shape of face and size of the airway in subjects with obstructive sleep apnoea syndrome
| ISRCTN | ISRCTN18399406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18399406 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/07/2015
- Registration date
- 19/02/2016
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Obstructive sleep apnoea- hypopnoea syndrome (OSAHS) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, completely (apnoea) or partially (hypoapnoea) blocking the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. Many studies have shown that people who are obese have a higher risk of developing it and that the incidence of OSAHS is increasing with the rise in obesity. Although there is a strong relationship with obesity however, this does not mean that all obese people have OSAHS and normal weight people do not. Previous studies have tried to use facial characteristics such as face shape (phenotype) to predict the occurrence of OSAHS, however this screening technique is widely debated. The aim of this study is to find out whether the visual characteristics of the face and neck (phenotyping) can be used in order to develop a new pre-screening tool for people suffering from OSAHS.
Who can participate?
Caucasian men aged between 45 and 65, either normal weight or obese who either have OSAHS or show no signs of it.
What does the study involve?
All participants then attend two study visits. At the first study visit, all participants complete a number of questionnaires as well as having their weight and height measured and medical history taken. Then then have a simple physical examination in order to assess their neck and facial characteristics. At the second study visit, participants all participants have a cone beam computed tomography scan (a high resolution type of x-ray) and have a 3D analysis of their facial characteristics. At the end of the second visit, the characteristics of all participants are compared between the those with OSAHS and those without.
What are the possible benefits and risks of participating?
There are no direct benefits to participants; however the participants with OSAHS may be able to gain a better understanding of the underlying causes of their condition. Participants are exposed to a very small amount of radiation during the scanning procedures, however this is not considered to be harmful.
Where is the study run from?
Bart’s & The London Dental Institute (UK)
When is the study starting and how long is it expected to run for?
November 2015 to November 2017
Who is funding the study?
Queen Mary University of London (UK)
Who is the main contact?
Dr Bahn Agha
b.g.m.agha@qmul.ac.uk
Contact information
Scientific
Bart’s & The London Dental Institute
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
 ORCID ID |
0000-0003-1672-5084 |
|---|---|
| Phone | +44 20 7882 8629 |
| b.g.m.agha@qmul.ac.uk |
Study information
| Study design | Single-centre case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | The relationship between facio-cervical phenotyping and upper airway morphology in obstructive sleep apnoea-hypopnoea syndrome: A 3-dimensional approach |
| Study objectives | Null hypotheses: 1. Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) subjects cannot be identified from their facio-cervical form (phenotype) 2. There is no correlation between the soft tissue facial morphology and underlying skeletal morphology 3. There is no correlation between the surface facial morphology and the upper airway of OSAHS subjects 4. It is not possible to identify or create a facio-cervical prediction tool (marker) for OSAHS subjects |
| Ethics approval(s) | London - City & East Research Ethics Committee, 17/05/2016, ref: 16/LO/0554 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) |
| Intervention | Interventions as of 02/06/2016: In the first study visit, both obstructive sleep apnoea-hypopnoea syndrome (OSAHS) diagnosed participants and suspected non-OSAHS participants will complete the consent form and undergo the baseline assessment including simple clinical examination to determine the number of teeth and examine the back of the throat (Mallampati airway classification (MAC)) and anthropometric measurements to measure the body mass index (BMI) and neck circumference (NC). Then the suspected non-OSAHS (healthy) subjects will be asked to complete a series of questions and undergo an overnight sleep test (at home). The sleep test and questions will help to identify if they suffer from obstructive sleep apnoea. At the second study visit, all participant will undergo cone-beam computed tomography (CBCT) first then three-dimensional (3D) stereophotogrammetry scan. For whole participation, the average time taken for each participant is around 1 hour ± 5 minutes (over the two visits). Original interventions: Both obstructive sleep apnoea-hypopnoea syndrome (OSAHS) diagnosed participants and healthy participants added a study visit which involves the completion of a consent form, history & clinical examination, weight and height assessment and pre-screening questionnaires. All participants will undergo a simple clinical examination (to determine the number of their teeth, body mass index (BMI), neck circumference (NC), and Mallampati airway classification (MAC). In addition, the control subjects (non-OSAHS), will complete pre-screening questionnaires (Epworth sleepiness scale (ESS), sleep apnoea clinical score (SACS) and sleep partner questionnaire (SPQ)) to exclude OSAHS. At a second visit, all participants undergo imaging procedures. OSAHS participants will undergo cone-beam computed tomography (CBCT) and then three-dimensional (3D) stereophotogrammetry scan and non-OSAHS participants will undergo a lateral cephalometric radiograph, followed by a 3D stereophotogrammetry scan. For whole participation, the average time taken for each participant is around 1 hour ± 5 minutes (over the two visits). |
| Intervention type | Mixed |
| Primary outcome measure | Facio-cervical morphology (phenotype)measured using image analysis software for stereophotogrammetry scan, lateral cephalometric radiograph, and cone-beam computed tomography (CBCT) at the second visit after baseline assessment. |
| Secondary outcome measures | 1. The correlation between the surface and skeletal facio-cervical morphology and upper airway dimensions using correlation analysis after the second visit 2. Potentially identifying a facio-cervical marker for OSAHS subjects using multiple regression analysis after the second visit |
| Overall study start date | 05/12/2014 |
| Completion date | 01/10/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 132 dentate Caucasian male adults meeting selection criteria |
| Key inclusion criteria | 1. 40 to 65 years old males 2. Clinically normal weight (BMI <25 Kg/m2) or obese (BMI >30Kg/m2) 3. Caucasian 4. Confirmed diagnosis of OSAHS in the study group and no clinically demonstrable OSAHS in control group 5. Dentate 6. The skin over the face and neck must be free of significant hair. |
| Key exclusion criteria | 1. Edentulous subjects or the absence of 8 or more teeth in each dental arch 2. Facial neuromuscular disorders, craniofacial deformity or history of craniofacial surgery 3. Overweight subjects (BMI between 25 and 30 Kg/m2) |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 01/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Garrod Building
Turner Street
London
E1 2AD
United Kingdom
Sponsor information
University/education
Queen Mary University of London
Turner Street
London
E1 2AD
England
United Kingdom
| Phone | +44 20 7882 8669 |
|---|---|
| j.frith@qmul.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the study will be published in peer-reviewed medical and dental journals. In addition, they will be presented at sleep conferences. A summary of the key findings will be sent to all participants. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
18/01/2019: The intention to publish date has been changed from 30/06/2018 to 31/07/2019
02/06/2016: Ethics approval information added. The interventions section has also been updated following review by the approving ethics committee.
15/03/2016: Internal review
