A study of the influence of pheromones on superosmia

ISRCTN	ISRCTN61835374
DOI	https://doi.org/10.1186/ISRCTN61835374
Secondary identifying numbers	N0274181493

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 16/01/2014

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Carl Philpott
Scientific

St Paul's Sinus Centre
St Paul's Hospital
1081 Burrard Street
Vancouver, BC
V6Z 1Y6
Canada

Phone	+1 604 806 9926
Email	carl.philpott@btinternet.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The aim of this study is to evaluate the whether pheromones can influence the occurrence of superosmia during an olfactory threshold test.
Ethics approval(s)	Added September 2008: UCLH Committee (UK), ref 06/Q0505/10, 04/08/06 (Ethics Approval), 18/05/07 (R&D Approval).
Health condition(s) or problem(s) studied	Ear, Nose and Throat: Superosmia
Intervention	The study will take place at the ENT departments of Leicester Royal Infirmary and the West Suffolk Hospital. One hundred subjects will be recruited from amongst hospital staff who consider themselves to have a 'normal' sense of smell and no active sino-nasal disease. The study will take the form of a single-blinded randomised controlled trial. Subjects selected will be invited to undergo a 15 minute smell test and examination of their nose. They will be tested with a computer-driven olfactometer which enables a quantitative threshold test to be performed for several odours: phenethyl alcohol (roses), eucalyptol (menthol), acetic acid (vinegar) and mercaptan (gas). These odours have been shown to represent distinct entities in an individuals sense of smell (1) and the test format has been validated in our previous work (2). The test involves the patient being seated in front of the olfactometer and the process of the test is explained to them by the researcher. At the voice prompts from the computer attached to the olfactometer, they will be asked to deliver two puffs of air from the spout using the two buttons attached to the olfactometers valve. The puffs of air are paired, one being a blank, the other containing the odour and they will be asked to identify the odour repeatedly like this in a forced response format until they have defined a threshold. Following this they will then be exposed to either a pheromone (delta4,16-androstadien-3-one for female subjects and 1,3,5,(10),16-estratetraen-3-ol for male subjects) or sterile water - 1cm3 of the solution will be placed on a mask and held in front of the subjects nose for 2 minutes. The substance applied to the mask will be determined by use of a closed envelope system. Subjects will be then retested for their olfactory thresholds using the technique described above. This whole process will take less than an hour and no further involvement will be required of the individual subjects. 1. Gaskin JA, Robinson A, Philpott CM, Goodenough PC, Murty GE. Are patients cross-sensitive to odours in parallel threshold tests Chemical Senses 2006 2. Philpott CM, Dhanji F, Wolstenholme CR, Goodenough PC, Clark A, Murty GE. Eucalyptol olfactory threshold testing with a computer driven olfactometer. Journal of Laryngology and Otology 2006 Updated 16/01/2014: The study did not proceed due to a lack of funds and personnel.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	pheromones
Primary outcome measure	Olfactory thresholds
Secondary outcome measures	No secondary outcome measures
Overall study start date	11/08/2008
Completion date	01/08/2009
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Number of participants: 100 total. 50 from West Suffolk.
Key inclusion criteria	Anyone who considers themselves to have a normal sense of smell.
Key exclusion criteria	People who are found to be hyposmic/anosmic (ie lacking in ability to detect odours at normal levels), people with sino-nasal disease, people unable to understand spoken English or who are mentally impaired.
Date of first enrolment	11/08/2008
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

Canada
United Kingdom

Study participating centre

St Paul's Sinus Centre

Vancouver, BC
V6Z 1Y6
Canada

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

University Hospitals of Leicester NHS Trust Headquarters
Level 3, Balmoral Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom

Website	http://www.uhl-tr.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

West Suffolk Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan