Plain English Summary
Background and study aims
There is considerable debate among scientists over why we yawn, and the mechanism of yawning is still not fully understood. About half of adults yawn after someone else yawns due to a phenomenon called contagious yawning. The aim of this study is to test whether levels of the hormone cortisol are higher during yawning and contagious yawning, just as cortisol levels are raised during stress and fatigue.
Who can participate?
Volunteers aged 18-65 will be recruited from students at Bournemouth University.
What does the study involve?
Participants are exposed to three conditions intended to provoke yawning – photos of people yawning, boring text about yawning, and a short video of a person yawning. We collect saliva samples from participants at the start and after yawning to measure saliva cortisol levels, and record the electrical activity of their jaw muscles via surface-placed electrodes. Questionnaires about yawning, anxiety and depression, general health, and demographic and health details are also collected from each participant.
What are the possible benefits and risks of participating?
The results of this study may improve our understanding of yawning and its role in many neurological disorders, and allow us to develop a diagnostic tool for neurological disorders. There are no risks involved. All participants will have the right to withdraw at any time and will be debriefed. All data is anonymised.
Where is the study run from?
Bournemouth University (UK).
When is the study starting and how long is it expected to run for?
June 2012 to December 2012.
Who is funding the study?
Bournemouth University and Santander plc (UK).
Who is the main contact?
Dr Simon Thompson
simont@bournemouth.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Simon Thompson
ORCID ID
Contact details
Bournemouth University
Talbot Campus
Poole House (P315)
Fern Barrow
Poole
BH12 5BB
United Kingdom
-
simont@bournemouth.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BU-PS5/10/11-PS1/3/12
Study information
Scientific title
Thompson Cortisol Hypothesis: trial to investigate the maintenance effects of Yawning on salivary Cortisol levels - an observational study
Acronym
TCH-YawnCort
Study hypothesis
Cortisol levels rise during the yawning episode
Ethics approval
Bournemouth University Research & Ethics Committee, 05/10/2011, ref: BU-PS5/10/11-PS1/3/12
Amendments approved 01/03/2012
Study design
Observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Salivary cortisol levels
Intervention
Collection of saliva samples; collection of non-invasive surface-placed electrode data of electrical nerve impulses around jaw-line during yawning.
Observing participants' yawning, their level of saliva cortisol before and after yawning, and their electrical (nerve) activity around the jaw muscles at rest and during yawning. The duration of observation is determined by the time it takes to view the stimuli (about 20 minutes) and to yawn. If yawning occurs before all the stimuli have been viewed, then the observation period is shorter for the participant as the stimuli merely serve to elicit a yawn. We aim to conduct a longitudinal study at a later date once data has been analysed and results are known.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Salivary cortisol levels - collection of saliva deposited (spit into tube) by each participant into sample bottle at start of study then again immediately after yawning, or if no yawn elicited, at end of last stimuli presentation
2. Electrical nerve activity - non-invasive surface-placed electrodes around the jaw line receive data throughout the study (20 mins maximum), or only until yawning is elicited, whichever happens first
Secondary outcome measures
Demographic and descriptive details of participants age, gender, ethnicity
Overall trial start date
01/06/2012
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 100 male and female volunteers aged between 18-65 years will be recruited from students at Bournemouth University using the computerised recruitment system (SONA), and Facebook
2. All participants will be properly consented according to code of conduct and research guidelines
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Chronic fatigue
2. Diabetes
3. Fibromyalgia
4. Heart condition
5. High blood pressure
6. Hormone replacement therapy
7. Multiple sclerosis
8. Stroke
Recruitment start date
01/06/2012
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bournemouth University
Poole
BH12 5BB
United Kingdom
Sponsor information
Organisation
Bournemouth University (UK)
Sponsor details
c/o Dr Simon Thompson
Associate Professor
Talbot Campus
Poole House (P315)
Fern Barrow
Poole
TS17 6QQ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Bournemouth University (UK) ref: BU-26.08.11
Alternative name(s)
BU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Funder name
Santander plc (UK) ref: SANTANDER-30.09
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23611879